• Follow department and company standard operating procedures (SOPs), forms, templates, and policies.
• On occasion, may act as senior Biostatistician for simple to complex studies and be the central point of contact for the assigned Biostatistics team, extended internal project team, and the client.
• Provide input for Biostatistics portion of project timelines.
• Review protocols for simple to complex studies.
• Generate randomization schedules using SAS or randomization-specific software.
• Develop and QC statistical analyses for simple to complex studies.
• Develop or assist in developing the Statistical Analysis Plans (SAPs) and related table, figure, and listing (TFL) shells.
• Develop tables of summary statistics and graphics for clinical trials.
• Assist in answering deficiency letters from regulatory agencies, as required.
• Utilize SAS to validate statistician programs and results.
• Perform QC review of analyses and documents prepared by others.
• Oversee nonclinical projects, work with line manager to direct activities of other Biostatisticians.
• Coordinate with internal teams to deliver quality documents on time.
• Represent Biostatistics in client and inter-departmental meetings.
• Conduct all work in compliance with SOPs, GCP, and regulatory guidelines.
• Maintain familiarity with client/internal expectations and ensure aligned analyses and documentation.
• Stay current on global regulatory requirements (FDA, EMA, ICH, GCP).
• May participate in or lead quality improvement initiatives.
• Other duties as assigned.

Education:
Master's Degree in Statistics or a related field required.

Core Competencies

• Excellent verbal and written communication
• Ability to communicate proactively and clearly with cross-functional teams to ensure alignment on study timelines, deliverables and issues.
• Professional attitude and strong interpersonal skills
• Collaborative, client-focused mindset
• Flexible with work assignments and learning
• Strong organizational and prioritization skills
• High attention to detail
• Understanding of clinical research life cycle and regulations
• Proficient in Microsoft Word, Excel, PowerPoint

Statistical & Technical Skills

• Own statistical deliverables from design through analysis (e.g., SAPs, TFLs)
• Moderate SAS programming proficiency, including the ability to perform inferential statistical analyses
• Review programming output for accuracy and alignment with SAP
• Protocol review
• Review of aCRF / eCRF
• Creating and reviewing SAPs
• Creating and writing TFL specs and shells
• Understanding of CDISC standards (SDTM, ADaM)
• SDTM specifications and domain review
• ADaM specification writing and domain review
• ADRG (Analysis Data Reviewer’s Guide) creation and review
• Pinnacle 21 review and input

• Follow department and company standard operating procedures (SOPs), forms, templates, and policies.
• On occasion, may act as senior Biostatistician for simple to complex studies and be the central point of contact for the assigned Biostatistics team, extended internal project team, and the client.
• Provide input for Biostatistics portion of project timelines.
• Review protocols for simple to complex studies.
• Generate randomization schedules using SAS or randomization-specific software.
• Develop and QC statistical analyses for simple to complex studies.
• Develop or assist in developing the Statistical Analysis Plans (SAPs) and related table, figure, and listing (TFL) shells.
• Develop tables of summary statistics and graphics for clinical trials.
• Assist in answering deficiency letters from regulatory agencies, as required.
• Utilize SAS to validate statistician programs and results.
• Perform QC review of analyses and documents prepared by others.
• Oversee nonclinical projects, work with line manager to direct activities of other Biostatisticians.
• Coordinate with internal teams to deliver quality documents on time.
• Represent Biostatistics in client and inter-departmental meetings.
• Conduct all work in compliance with SOPs, GCP, and regulatory guidelines.
• Maintain familiarity with client/internal expectations and ensure aligned analyses and documentation.
• Stay current on global regulatory requirements (FDA, EMA, ICH, GCP).
• May participate in or lead quality improvement initiatives.
• Other duties as assigned.

Education:
Master's Degree in Statistics or a related field required.

Core Competencies

• Excellent verbal and written communication
• Ability to communicate proactively and clearly with cross-functional teams to ensure alignment on study timelines, deliverables and issues.
• Professional attitude and strong interpersonal skills
• Collaborative, client-focused mindset
• Flexible with work assignments and learning
• Strong organizational and prioritization skills
• High attention to detail
• Understanding of clinical research life cycle and regulations
• Proficient in Microsoft Word, Excel, PowerPoint

Statistical & Technical Skills

• Own statistical deliverables from design through analysis (e.g., SAPs, TFLs)
• Moderate SAS programming proficiency, including the ability to perform inferential statistical analyses
• Review programming output for accuracy and alignment with SAP
• Protocol review
• Review of aCRF / eCRF
• Creating and reviewing SAPs
• Creating and writing TFL specs and shells
• Understanding of CDISC standards (SDTM, ADaM)
• SDTM specifications and domain review
• ADaM specification writing and domain review
• ADRG (Analysis Data Reviewer’s Guide) creation and review
• Pinnacle 21 review and input

Our client is a biopharmaceutical company focusing in the Ophthalmology space. They are focused on bringing new science to the design and manufacture of next-generation retinal medicines with the goal of preventing and treating leading causes of blindness worldwide. Here you’ll have the opportunity to work alongside talented, cross-functional teams in an environment where scientific innovation, collaboration, and high-quality execution are highly valued.

Currently they are seeking a Manager, Data Management to support clinical trial data management activities and help ensure the integrity, quality, and readiness of clinical data throughout the development process. This is an excellent opportunity for a hands-on data management professional who thrives in a collaborative, cross-functional environment and is motivated by the opportunity to contribute to innovative therapies for patients with retinal diseases.

The Opportunity

As Manager, Data Management, you will play an important role in the execution of clinical trials, supporting database development, data quality oversight, vendor management, and preparation of submission-ready datasets. You will collaborate closely with internal teams and external partners to ensure clinical data is accurate, compliant, and delivered on time to support key study milestones and regulatory submissions.

What You’ll Do

• Support the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level.
• Oversee data cleaning, query management and resolution, and delivery of high-quality datasets in support of clinical trial milestones and regulatory submissions.
• Partner with external data management vendors to ensure timely, high-quality deliverables and monitor performance against project timelines and quality standards.
• Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings, including NDA, BLA, and MAA submissions.
• Ensure data management activities comply with applicable industry standards and regulations, including GCP, FDA, and EMA requirements.
• Support audit and inspection readiness activities.
• Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, IT, and other cross-functional partners to facilitate effective data integration, review, and reporting.
• Contribute to the implementation, enhancement, and optimization of clinical data systems and tools, including EDC and data review platforms.
• Identify opportunities to improve data management processes, systems, and overall study execution.

What You’ll Bring

• Bachelor’s degree in Life Sciences, Data Science, Computer Science, or a related field.
• 7+ years of clinical data management experience within the biotechnology, pharmaceutical, or CRO industry.
• Hands-on experience managing study-level data management activities.
• Demonstrated experience working with and overseeing external data management vendors.
• Familiarity with clinical data management systems such as Medidata RAVE, Oracle Clinical, and/or Veeva.
• Knowledge of clinical data standards, including CDISC and SDTM.
• Experience supporting regulatory submissions is strongly preferred.
• Strong problem-solving and analytical skills, with exceptional attention to detail.
• Excellent organizational and project management skills, with the ability to manage multiple priorities and timelines.
• Strong written and verbal communication skills and the ability to collaborate effectively across functions.

This is a hands-on development role for a strong R/Shiny developer who understands clinical trial data and can work directly with clinical study and Biometrics stakeholders to understand their needs and translate them into practical, user-friendly applications, dashboards, and visualizations.

The ideal candidate is a strong R/Shiny developer who understands clinical trial data and can work directly with stakeholders to understand their needs and translate them into practical, user-friendly applications and visualizations.

The primary focus of this role is hands-on development and delivery of Shiny applications and dashboards, rather than building broader technical infrastructure or platforms.

Primary Responsibilities

• Design, develop, and maintain interactive R Shiny applications and dashboards supporting clinical studies and Biometrics teams.
• Work directly with stakeholders to gather requirements and translate business and clinical needs into practical Shiny applications.
• Work with clinical trial data to create tools that improve data access, review, visualization, and decision-making.
• Partner closely with Biostatistics, Statistical Programming, Data Management, and other clinical and technical stakeholders.
• Build applications that allow users to effectively explore, visualize, and interact with clinical study data.
• Enhance and maintain existing Shiny applications as study and stakeholder requirements evolve.
• Develop reusable Shiny components and approaches where appropriate.
• Troubleshoot application, data, and visualization issues and implement practical solutions.
• Participate in application testing, validation, and quality review.
• Communicate effectively with both technical and non-technical stakeholders throughout the development process.

Required Qualifications

• Bachelor's or Master's degree in Data Science, Statistics, Biostatistics, Computer Science, or a related quantitative field.
• Strong hands-on R programming and R Shiny development experience.
• Demonstrated experience personally building Shiny applications, dashboards, and interactive data visualizations.
• Experience developing reusable Shiny modules or components.
• Experience working with clinical trial data within pharmaceutical, biotechnology, CRO, or a related clinical research environment.
• Experience working directly with stakeholders to understand requirements, incorporate feedback, and deliver functional applications.
• Strong understanding of data manipulation and visualization (static and dynamic) in R.
• Experience working with databases or other clinical data sources.
• Familiarity with Git/GitHub and collaborative development practices.
• Strong communication skills and ability to work effectively across technical and clinical functions.
• Ability to work independently and take ownership of Shiny development from requirements through delivery.
• Comfortable working in a fast-moving organization with evolving priorities.

Preferred Experience

• Experience developing Shiny applications specifically for clinical data review, study analytics, or Biometrics teams.
• Experience working alongside Biostatistics, Statistical Programming, and Clinical Data Management.
• Experience with SAS and/or Python is beneficial but not required as a primary skill set.

The successful candidate will be:

• A hands-on Shiny developer. Has meaningful experience personally building applications and dashboards rather than simply supporting or overseeing development.
• Clinical-data savvy. Understands clinical trial data and can apply that knowledge when developing applications and visualizations.
• Stakeholder-oriented. Can gather requirements, ask the right questions, incorporate feedback, and translate stakeholder needs into effective applications.
• Delivery-focused. Enjoys building and delivering useful apps and dashboards and is comfortable spending the majority of their time doing hands-on development.
• Practical. Focused on building effective, usable solutions without overengineering.
• Independent and collaborative. Can own development work while partnering closely with clinical and Biometrics stakeholders.

This role sits at the intersection of data engineering and applied AI, partnering closely with Clinical Operations, Data Management, Regulatory, and IT to design, build, and maintain modern data platforms and AI-enabled pipelines that underpin the transformation program.

The ideal candidate brings deep expertise in clinical data infrastructure and modern data engineering, combined with hands-on experience deploying machine learning solutions in regulated life sciences environments. This role will act as both a technical authority and strategic liaison between transformation projects and enterprise IT, ensuring that solutions are scalable, compliant, and aligned with evolving regulatory and data standards.

Location: New Jersey Preferred. Remote may be considered for highly qualified candidates.

Key Responsibilities

• Translate ambiguous clinical and operational problems into well-scoped AI solutions, from problem framing and data assessment through prototype, validation, and production deployment.
• Design and implement MLOps/LLMOps pipelines to deploy, monitor, and manage large language models in production environments, following software engineering best practices.
• Collaborate with data scientists to deploy and/or fine-tune high-performing Generative AI models and apply modern techniques from relevant published work where appropriate.
• Develop scalable and robust data and ML pipelines for ingestion, preprocessing, validation, training, evaluation, and model deployment across the clinical development ecosystem.
• Evaluate and recommend AI tools and frameworks to meet clinical and operational requirements, including decisions around retrieval-augmented generation (RAG), vector databases, embedding models, and LLM providers, balancing compliance, performance, and cost.
• Develop, deploy, and maintain robust data pipelines for structured and unstructured clinical data, integrating internal systems with CRO and external partner data sources and ensuring end-to-end data integrity and traceability.
• Identify and implement opportunities to increase data interoperability and standardization across Global Development systems and other business units, reducing manual effort and accelerating data availability for clinical programs.
• Develop and implement automated quality monitoring pipelines for both internal and CRO-sourced clinical data, surfacing quality metrics and triggering corrective workflows in alignment with the study’s Medical Monitoring Plan.
• Ensure all data solutions comply with applicable regulatory frameworks, including HIPAA, GDPR, and 21 CFR Part 11, and contribute to data governance strategy, data lineage documentation, and audit readiness.
• Maintain and manage code repositories such as Bitbucket and GitHub with clean, well-documented, version-controlled code; uphold engineering best practices including code review, testing, and CI/CD pipelines.

 Qualifications

• Advanced degree in computer science, biomedical informatics, statistics, or a closely related field required; PhD with 6+ years of relevant experience or MS with 10+ years of relevant experience strongly preferred.
• Minimum of 5–7 years of experience designing, implementing, and leading data engineering solutions in life sciences or healthcare, with demonstrated accountability for end-to-end delivery.
• Demonstrated expertise in designing and maintaining clinical or biomedical data infrastructure, including data lake and warehouse architectures optimized for regulatory-grade clinical data.
• Expertise in modern cloud data platforms such as Snowflake, Databricks, Redshift, and BigQuery, with proficiency in Python, SQL, R, and related programming languages.
• Proficiency in cloud architecture (AWS, Azure, or GCP) and DevOps practices including CI/CD, containerization (Docker/Kubernetes), and infrastructure-as-code; relevant certifications are a plus.
• Demonstrated experience building, scaling, and maintaining pipelines for structured and unstructured data, with the ability to integrate pipelines across the enterprise.
• Deep knowledge of regulatory frameworks (HIPAA, GDPR, 21 CFR Part 11) and clinical data standards (CDISC, HL7, FHIR), with experience applying them in regulated development environments.
• Hands-on experience developing or integrating machine learning pipelines and working with clinical AI/ML applications such as natural language processing, anomaly detection, or predictive modeling.
• Strong scientific communication skills, with the ability to translate complex technical architectures and outputs into clear strategic recommendations for non-technical clinical and executive stakeholders.
• Experience with data governance frameworks, data quality tooling, and metadata management practices in clinical or regulated settings.

 Ideal Candidate Profile

• A builder at heart—someone who moves fluidly from whiteboard to working solution and is comfortable owning the full arc from idea through deployed product.
• Able to assess a clinical or operational challenge and independently determine whether and how AI can meaningfully solve it—not simply implement what is handed to them.
• A natural cross-functional collaborator who earns the trust of clinical, operations, regulatory, and IT stakeholders alike and is comfortable operating as both a technical lead and strategic partner.
• Solutions-oriented and innovation-driven, with the confidence to constructively challenge legacy thinking and the pragmatism to deliver within the constraints of a regulated environment.
• Thrives in ambiguity and fast-moving environments, able to balance long-horizon architectural thinking with near-term delivery commitments across multiple concurrent transformation workstreams.
• A proactive learner who actively monitors advances in AI/ML, data engineering, and clinical informatics and brings external insights back to accelerate the program’s evolution.

Contact: Alexandra Spink - aspink@penfieldsearch.com
No 3rd party candidates

We are seeking a hands-on, detail-oriented professional to support Quality Control (QC), submission readiness, and medical writing operations. This role will partner closely with the Head of Medical Writing and QC team to ensure high-quality, compliant clinical and regulatory documents while optimizing vendor workflows and operational processes.

This is a multi-hat role, with responsibilities spanning QC, document publishing, CSR appendices, redaction, lay summaries, and submission readiness - not QC alone.

Key Responsibilities

• Lead QC of clinical and regulatory documents, including protocols, CSRs, IBs, clinical summaries, and plain language materials.
• Support submission readiness and document publishing, including document completeness, consistency, formatting, version control, bookmarks, hyperlinks, tables of contents, pagination, and other final production elements.
• Coordinate and QC CSR appendices, including completeness, consistency, formatting, and submission-ready preparation. Hands-on CSR appendix experience is a key requirement.
• Review Tables, Listings, and Figures (TLFs) and supporting clinical documentation for accuracy, consistency, formatting, and alignment with the primary document.
• Identify and troubleshoot document production issues and work with writers, vendors, and other stakeholders to resolve.
• Utilize document publishing and production tools (e.g., ISI Toolbox or similar systems) to support document preparation, navigation, and submission readiness.
• Manage document redaction activities to support global transparency and disclosure requirements.
• Support development and QC of lay/plain language summaries, including Plain Language Protocol Summaries and other patient-facing materials.
• Support dashboards, metrics, and continuous improvement initiatives across the Medical Writing function.
• Collaborate cross-functionally to ensure high-quality, compliant, audit- and submission-ready documentation.

Qualifications

• Advanced degree in life sciences (PhD or PharmD preferred).
• 7+ years of experience in medical writing, QC, publishing, and/or medical writing operations within pharma, biotech, or CRO environments.
• Strong experience with QC, CSR appendices, document publishing, and submission readiness.
• Working knowledge of TLFs and clinical study documentation, with the ability to identify inconsistencies and production issues.
• Experience with document production tools such as ISI Toolbox or similar publishing systems; familiarity with bookmarks, hyperlinks, TOCs, and other submission-ready document features.
• Expertise in redaction and document compliance/transparency requirements.
• Experience with lay/plain language summaries and clinical/regulatory documents.
• Solid understanding of ICH/GCP and familiarity with document management systems.
• Strong operational mindset with experience improving processes and managing vendors.
• Excellent attention to detail, organization, and ability to manage multiple priorities and contribute across functions.

The Sr. Clinical Study Manager will provide operational leadership and mentorship to Clinical Operations staff and will collaborate closely with cross-functional teams to ensure clinical studies are executed according to established timelines, budgets, quality standards, and regulatory requirements.

This is a remote position with travel to company headquarters and/or clinical sites on a minimal and as-needed basis.

Key Responsibilities

• Manage the full scope of clinical studies from planning through completion.
• Oversee Clinical Operations staff, including regular and contract personnel, and manage all aspects of the clinical operational plan.
• Develop study-related documents and provide overall direction to clinical sites, including support for protocol development and implementation.
• Create, manage, and monitor clinical study budgets.
• Develop contingency plans and risk-mitigation strategies for clinical studies.
• Manage study timelines, milestones, resources, and deliverables to ensure successful execution.
• Oversee and manage CRO activities, when applicable.
• Develop and maintain effective communication across functions, including Executive/Leadership, Research & Development, Medical Affairs, Scientific Affairs, Regulatory Affairs, Finance, and Commercial teams.
• Provide regular reporting on study timelines, milestones, budget, and operational performance, with recommendations for adjustments as needed.
• Support compliance with applicable regulatory requirements, company procedures, and clinical research standards.
• Provide guidance, oversight, and mentorship to Clinical Operations team members.

• Bachelor's degree in a scientific discipline or equivalent combination of education and experience.
• 8+ years of clinical research experience within the medical device, in vitro diagnostics (IVD), biotechnology, or pharmaceutical industry.
• Working knowledge of applicable FDA regulatory requirements related to clinical research.
• Strong oral and written communication skills.
• Strong technical writing and documentation skills.
• Ability to effectively collaborate with cross-functional teams and external partners.
• Ability and willingness to travel up to 20% under normal operating conditions.

Preferred Qualifications

• At least 3 years of Clinical Research Associate (CRA) experience and 3 years of clinical study management experience.
• Experience managing in vitro diagnostic clinical trials.
• Experience with infectious disease and/or oncology clinical trials.
• Experience managing clinical studies through CROs and external clinical partners.
• Experience developing and implementing clinical operational plans, budgets, timelines, and risk-mitigation strategies.

Contact: Alexandra Spink - aspink@penfieldsearch.com

We are seeking a Director of Nursing to lead clinical nursing operations within a fast-paced oncology and clinical research environment. This role provides leadership and oversight for clinic nurses, infusion nurses, nurse navigators, referral intake teams, schedulers, and related clinical staff.

The Director of Nursing will provide professional guidance and development to nursing and support teams, ensure departmental goals and objectives are achieved, and promote ongoing training, education, regulatory compliance, operational efficiency, and high-quality patient care.

Must be onsite in one of the following locations:
Locations: Miami, FL; Los Angeles, CA; Pittsburgh, PA
Schedule: Monday - Friday, 8:00 a.m. - 5:00 p.m.

Essential Responsibilities

• Provide effective, proactive leadership to clinical and administrative team members, including managers, clinic nurses, infusion nurses, nurse navigators, schedulers, and referral intake staff.
• Develop, implement, and maintain effective training programs and ensure competency across applicable clinical and operational roles.
• Ensure adherence to organizational policies, standard operating procedures, clinical standards, and applicable regulatory requirements.
• Promote high-quality, coordinated patient care by supporting timely communication, care planning, scheduling, and follow-up.
• Provide clinical leadership and guidance to study coordinators, primary nurses, treatment room nurses, and other clinical research personnel.
• Serve as a nurse educator and preceptor for new clinical research and nursing staff.
• Develop and deliver training and education programs designed to support quality, compliance, and operational excellence.
• Ensure efficient, effective processes and systems are in place to support patient care workflows and compliant clinical research operations.
• Use continuous improvement methodologies to identify operational challenges, improve workflows, and enhance the patient and staff experience.
• Review incoming clinical research protocols for feasibility from a nursing and operational perspective.
• Support equitable and effective allocation of studies and responsibilities across clinical research team members.
• Establish, monitor, and maintain operational standards and performance metrics related to referrals, new patient visits, screening, enrollment, and other key research processes.
• Partner with clinical and operational leadership to support enrollment growth and identify and address barriers to timely patient access and study participation.
• Foster effective communication and collaboration with regulatory, quality, site development, pharmacy, finance, and other support functions.
• Support the effective implementation and utilization of clinical technology systems, including CTMS, EHR, and other platforms necessary for accurate documentation, data capture, and operational management.
• Provide leadership to nurse navigation functions and support organizational goals related to patient referrals, access, and clinical research enrollment.
• Promote a culture of accountability, collaboration, professional development, patient-centered care, and continuous improvement.

Required Education and Experience

• Bachelor’s degree in Nursing (BSN) or equivalent nursing education.
• Active, unrestricted RN license in the applicable state.
• Completion of an ONS/ONCC chemotherapy and immunotherapy certificate course.
• Working knowledge of Good Clinical Practice (GCP), applicable federal clinical research regulations, and relevant privacy and data protection requirements.
• Proficiency with Microsoft Office and electronic clinical documentation systems.
• Demonstrated leadership experience in a clinical or healthcare setting.

Preferred Education and Experience

• Advanced degree in nursing, healthcare administration, leadership, or a related field.
• Oncology Certified Nurse (OCN) certification.
• Previous experience in oncology, hematology, clinical research, or clinical trial operations.
• Experience leading multidisciplinary clinical teams in a research or specialty-care environment.

Physical and Travel Requirements

• Ability to travel approximately 5% of the time.
• Role involves prolonged periods of sitting and computer-based work.
• Ability to work effectively in a fast-paced, changing healthcare environment.
• Ability to manage competing priorities, demanding deadlines, and time-sensitive patient and operational needs.
• Commitment to maintaining current clinical, regulatory, and operational knowledge.
• Frequent collaboration with physicians, nurses, research personnel, and ancillary healthcare professionals involved in oncology and hematology patient care.

Salary Range: $140,000-200,000

About the Organization

The organization operates specialized clinical research sites focused on advancing new therapies and improving access to innovative treatment options. Clinical teams work closely with physicians, research professionals, patients, and industry partners to conduct clinical trials across a range of therapeutic areas, with a particular focus on oncology and early-phase research.

The organization is committed to maintaining high standards of patient care, research quality, regulatory compliance, and operational excellence while helping accelerate the development of new therapies.

Contact: Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates

The study support Biostatistician will provide statistical support across multiple clinical studies, working closely with senior biostatisticians to help manage study deliverables, analyses, and day-to-day statistical activities. This role is ideal for an early-career biostatistician with pharmaceutical industry experience who is comfortable working across multiple studies and contributing to a variety of statistical deliverables.

The individual will support two biostatisticians who oversee a broad portfolio of studies, helping ensure statistical activities are completed accurately, efficiently, and according to study timelines.

Responsibilities

• Provide statistical support for multiple clinical studies under the guidance of senior biostatisticians.
• Assist with the development, review, and quality control of statistical deliverables, including tables, figures, and listings (TFLs).
• Support the development and review of statistical analysis plans (SAPs), table shells, specifications, and other study documentation.
• Perform statistical analyses and assist with the interpretation of clinical study data.
• Review clinical data, outputs, and programming deliverables for accuracy, consistency, and completeness.
• Collaborate with Statistical Programming, Data Management, Clinical, and other cross-functional team members to support study activities and timelines.
• Assist with responding to statistical and data-related questions from study team members.
• Participate in study team meetings and provide statistical support as needed.
• Support database review, data cleaning activities, and preparation for database lock.
• Assist senior biostatisticians with ad hoc analyses, presentations, publications, regulatory requests, and other statistical deliverables.
• Maintain appropriate documentation and ensure work is performed in accordance with applicable SOPs, regulatory requirements, and industry standards.
• Effectively prioritize assignments across multiple concurrent studies and communicate potential timeline or resource concerns.

Qualifications

• Master’s degree in Biostatistics, Statistics, or a related quantitative discipline preferred.
• Approximately 3–5 years of biostatistics experience within the pharmaceutical, biotechnology, or related clinical research industry.
• Experience supporting clinical trials and working with clinical study data.
• Working knowledge of statistical methodologies commonly used in clinical research.
• Working proficiency in SAS and R, including experience performing statistical analyses and reviewing statistical outputs.
• Familiarity with CDISC standards, including SDTM and ADaM, preferred.
• Experience reviewing TFLs and other statistical programming outputs.
• Understanding of clinical trial processes, GCP, and regulatory expectations.
• Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
• Strong communication and collaboration skills with the ability to work effectively under the direction of more senior biostatisticians.

Ideal Candidate
The ideal candidate is a collaborative, detail-oriented biostatistician who enjoys being hands-on and supporting multiple studies. This individual does not need to be a senior study lead but should have enough pharmaceutical industry experience to understand clinical trial workflows, take ownership of assigned statistical tasks, and provide dependable support with limited day-to-day supervision.

The ideal consultant is a senior biostatistician with significant regulatory strategy experience and a strong understanding of FDA expectations for clinical evidence generated outside the United States, particularly studies conducted in China. This role will serve as a strategic advisor, helping the team identify potential statistical or regulatory risks, gaps, and considerations associated with the study designs.

Responsibilities

• Review clinical study designs and statistical methodologies for studies conducted in China.
• Assess study designs from both a biostatistical and U.S. regulatory perspective, with particular focus on FDA review expectations.
• Provide strategic guidance regarding the potential acceptability and applicability of China-generated clinical data in support of U.S. regulatory objectives.
• Evaluate statistical considerations including study design, endpoints, analysis populations, sample size, methodology, and interpretation of results.
• Identify potential statistical, methodological, or regulatory gaps that could affect FDA review or acceptance of clinical evidence.
• Advise on differences or considerations between China-based clinical development approaches and U.S. FDA expectations.
• Recommend strategies to address identified gaps or risks and strengthen the overall evidence package.
• Partner with clinical, regulatory, and statistical stakeholders to provide clear, actionable recommendations.
• Participate in targeted discussions and strategic reviews on an as-needed, part-time basis.

Qualifications

• Advanced degree (PhD strongly preferred) in Biostatistics, Statistics, or a related quantitative discipline.
• Significant biostatistics experience within the pharmaceutical or biotechnology industry.
• Prior FDA experience or extensive direct experience supporting FDA interactions, submissions, and regulatory strategy.
• Demonstrated understanding of how the FDA evaluates clinical studies and clinical evidence generated in China and other ex-U.S. regions.
• Experience reviewing clinical study designs and statistical approaches from a regulatory perspective.
• Strong knowledge of FDA expectations related to clinical trial design, statistical methodology, and interpretation of clinical evidence.
• Experience providing strategic statistical guidance for regulatory submissions and/or interactions with regulatory authorities.
• Ability to identify potential regulatory and statistical risks and translate complex issues into practical recommendations.
• Experience working with China-based clinical development programs or evaluating China-generated clinical data for U.S. regulatory purposes strongly preferred.

The Biostatistician applies statistical expertise across clinical research projects, independently supporting or leading studies, performing statistical analyses, and delivering high-quality statistical documents and outputs in support of sponsors' clinical development programs.

The ideal candidate has strong applied biostatistics experience and proficiency in SAS and R, including tables, figures, and listings (TFLs), inferential analyses, and randomization. This individual will collaborate with Statistical Programming, Data Management, Clinical, and other cross-functional teams while independently contributing to statistical deliverables and quality review.

Experience supporting Phase 1 and early clinical development studies is strongly preferred, including familiarity with early-phase study designs, safety and tolerability endpoints, pharmacokinetic/pharmacodynamic (PK/PD) data, dose escalation, and exploratory analyses.

Responsibilities

• Follow company SOPs, templates, processes, and policies.
• Serve as the study Biostatistician for assigned clinical trials and statistical point of contact for internal teams and clients, as appropriate.
• Provide statistical input into study design, protocols, project timelines, and clinical development activities.
• Review clinical study protocols and provide statistical recommendations.
• Develop randomization schedules using SAS, R, or other validated software, as applicable.
• Develop, perform, and QC statistical analyses for clinical studies.
• Develop or contribute to Statistical Analysis Plans (SAPs), including TFL specifications and shells.
• Develop and review summary statistics, inferential analyses, TFLs, and graphical displays.
• Support analyses of safety, tolerability, PK/PD, and other clinical endpoints, as applicable.
• Use SAS, R, and other statistical tools to perform or validate analyses and results.
• Review programming outputs for accuracy and consistency with protocols and SAPs.
• Perform QC review of statistical analyses, specifications, outputs, and documents.
• Collaborate with Statistical Programming, Data Management, Clinical, Medical, and other teams to ensure timely, accurate delivery of study outputs.
• Represent Biostatistics in client, study team, and cross-functional meetings.
• Support regulatory submissions and responses to regulatory questions as needed.
• Conduct work in accordance with SOPs, GCP, and applicable regulatory guidelines.
• Maintain knowledge of applicable regulatory requirements and guidance, including FDA, EMA, ICH, and GCP.
• Participate in process and quality improvement initiatives as appropriate.
• Perform other duties as assigned.

Education

• Master's degree in Statistics, Biostatistics, or a related quantitative field required.

Core Competencies

• Excellent written and verbal communication skills.
• Ability to communicate effectively with cross-functional teams regarding timelines, deliverables, statistical considerations, and issues.
• Strong interpersonal skills and a collaborative, client-focused approach.
• Ability to work independently and effectively within a team.
• Strong organizational and prioritization skills with high attention to detail.
• Flexibility in managing changing priorities and study requirements.
• Understanding of the clinical research lifecycle and applicable regulations.
• Proficiency with Microsoft Word, Excel, and PowerPoint.

Statistical & Technical Skills

• Ability to support or own statistical deliverables from study design through analysis and reporting.
• Proficiency in SAS and R, including statistical programming, data analysis, and inferential statistical methods.
• Experience developing and reviewing SAPs and TFL specifications and shells.
• Ability to review statistical programming outputs for accuracy and alignment with study specifications and SAPs.
• Experience reviewing clinical study protocols.
• Familiarity with aCRFs, eCRFs, and clinical data structures.
• Working knowledge of CDISC standards, including SDTM and ADaM.
• Ability to review SDTM and ADaM datasets and specifications from a statistical perspective.
• Experience with Phase 1 or early-phase clinical trials preferred.
• Familiarity with early-phase analyses, including safety, tolerability, PK/PD, dose escalation, and exploratory endpoints, preferred.

• Design, build, program, test, deploy, and maintain clinical trial databases in Medidata Rave in accordance with study requirements, company standards, and industry best practices.
• Translate study protocols and data collection requirements into effective eCRF and clinical database designs.
• Schedule and lead eCRF design and review meetings with Data Management and cross-functional study team members.
• Develop and maintain eCRFs, edit checks, validations, derivations, forms, fields, folders, dictionaries, and other database components within Medidata Rave.
• Perform ongoing post-production database maintenance, including database amendments, configuration changes, edit check updates, troubleshooting, and other modifications required throughout the study lifecycle.
• Assess the impact of database changes and perform appropriate programming, testing, documentation, deployment, and post-production verification.
• Develop, review, execute, and document database testing and User Acceptance Testing (UAT) to ensure database functionality and data quality prior to production release and following database amendments.
• Review and maintain validation/edit checks for both internally managed and outsourced studies.
• Perform traditional clinical data management activities as needed, including data review, query generation and resolution, discrepancy management, data cleaning, reconciliation, and preparation for database freeze and lock.
• Monitor production databases and identify and resolve database, data entry, edit check, and data quality issues.
• Provide technical expertise, troubleshooting, and ongoing database support to the Clinical Data Management team.
• Routinely interface with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, and other cross-functional team members.
• Act as a liaison with CROs and external vendors and support the development and maintenance of external data transfer specifications.
• Retrieve, load, review, and reconcile data received from CROs, central laboratories, and other external vendors.
• Develop, program, test, and maintain data review listings and tools using JReview, SAS, and/or other applicable technologies to support ongoing data review and cleaning activities.
• Perform post-processing of clinical data extracts in accordance with applicable standards for delivery to Biostatistics and Statistical Programming.
• Ensure database design and data collection standards support CDISC/CDASH requirements and downstream SDTM programming.
• Support user access, roles, permissions, and other study-level database configuration as needed.
• Make clinical data available to appropriate company personnel and regulatory agencies when required.
• Manage multiple study priorities and timelines while ensuring database programming and maintenance deliverables are completed accurately and on schedule.
• Develop and maintain appropriate database and Data Management documentation throughout the study lifecycle.
• Follow applicable SOPs, FDA/ICH guidelines, GCP, GCDMP, and industry standards.

• Master’s degree in Computer Science, Life Sciences, Health Sciences, Mathematics, Statistics, or a related scientific or technical discipline.
• Minimum of 5 years of clinical database programming and/or clinical data management experience within the pharmaceutical, biotechnology, or clinical research industry.
• Advanced hands-on Medidata Rave database programming and build experience is required.
• Demonstrated ability to independently design, build, program, test, deploy, and maintain clinical databases in Medidata Rave.
• Strong experience with eCRF design, database configuration, edit check programming, validation, testing/UAT, database amendments, and production database maintenance.
• Experience supporting databases throughout the complete study lifecycle, including post-build maintenance through database freeze and lock.
• Hands-on knowledge of traditional clinical data management activities, including data cleaning, query management, discrepancy resolution, reconciliation, and database lock activities.
• Detailed knowledge of clinical database design, case report form design, data validation, central laboratory data, and external/vendor data.
• Strong understanding of clinical trial design and the relationship between Clinical Data Management, Biostatistics, Statistical Programming, and Clinical Operations.
• Knowledge of FDA/ICH guidelines, GCP, GCDMP, and applicable industry standards.
• Knowledge of SQL and experience working with clinical data extracts and data transfer processes.
• Ability to work effectively with Data Managers, clinical personnel, medical staff, statisticians, statistical programmers, and other cross-functional partners.
• Strong analytical, troubleshooting, organizational, and problem-solving skills.
• Excellent verbal and written communication skills.
• Ability to independently manage competing priorities and study timelines while maintaining a high level of accuracy and attention to detail.

Our client is an established biopharmaceutical company seeking a senior Biostatistics leader to support Medical Affairs and external-facing scientific communications. This is a high-impact opportunity for a Biostatistician who enjoys working at the intersection of science, strategy, data, and cross-functional collaboration. 

What You’ll Do:

• Lead statistical and programming efforts supporting medical publications, scientific congresses, and external collaborations
• Provide statistical expertise to Medical Affairs strategy, publication planning, and evidence-generation initiatives
• Guide the design and analysis of investigator-initiated research and collaborative studies
• Develop and maintain Supplemental Statistical Analysis Plans (SAPs)
• Partner with Medical Affairs, Clinical Biostatistics, Statistical Programming, Translational Medicine, and Project Management
• Develop exploratory and ad hoc analyses to uncover scientific insights and evidence-generation opportunities
• Support RWE and HEOR initiatives as needed
• Serve as the primary biostatistics point of contact for Medical Affairs 

Qualifications:

• PhD + 8+ years of relevant pharmaceutical/biotech experience, or MS + 15+ years
• Strong experience in post-approval / Medical Affairs biostatistics
• Extensive publication record 
• Experience with propensity score matching and linear models for repeated measures
• Deep knowledge of statistical methodology, drug development, and regulatory environments
• Proven experience supporting scientific publications and external scientific communication
• Strong programming skills, with R and/or SAS fluency preferred
• Ability to independently develop publication-ready figures and analyses
• Excellent communication skills and the ability to work effectively with both technical and non-technical stakeholders
• Comfortable operating in a fast-paced, matrixed environment

Location: Remote with some travel

This is an excellent opportunity for a seasoned biostatistician who wants to have a strategic impact on Medical Affairs, scientific communication, and evidence generation.

#Biostatistics #MedicalAffairs #Biopharma #PharmaJobs #BiotechJobs #ClinicalResearch #RWE #HEOR #Statistics #Hiring #LifeSciences #PharmaCareers

The Manager, Biostatistics is responsible for conducting biostatistical activities to support all phases of clinical development and post-marketing efforts. This role will collaborate closely with other biostatisticians, statistical programmers, and cross-functional team members, as well as with contract research organization (CRO) partners and other vendors to meet company R&D objectives. Individuals in this role will support the development and review of statistical deliverables and provide high-quality analytical outputs to inform clinical and regulatory decision-making.

Essential Duties & Responsibilities:

Provide statistical leadership for one or more clinical development programs, ensuring consistency and quality of statistical deliverables.
Manage statistical responsibilities of clinical studies from program development through CSR creation and publication, collaborating with other statisticians and statistical programmers.
Serve as the primary statistical point of contact for assigned programs and studies.
Serve as a key contributor to protocol development and study design.
Perform sample size calculations.
Develop and/or review statistical analysis plans.
Contribute to the design and analysis of clinical trial and real-world data to support evidence generation for company products from randomized controlled trials and observational studies.
Establish effective collaboration with cross-functional team members, including clinical development, medical affairs, clinical operations, data management, and regulatory affairs.
Review and approve statistical deliverables produced internally or by CRO partners, ensuring high quality deliverables and compliance with regulatory standards and company expectations.
Manage biostatistics CRO partners, ensuring quality and adherence to SOPs.
Partner with clinical and regulatory teams to proactively identify risks and mitigation strategies related to statistical design and analysis.
Support interactions with regulatory authorities on statistical topics, including participation in meetings, responses to information requests, development of preparation materials and briefing book materials for meetings and communications with regulatory authorities.

Education and Experience:

Master’s Degree in statistics, biostatistics from accredited college or university
Minimum 2 years of experience within the biotech/pharmaceuticals industry or a related field.
Experience in statistical responsibilities for design, analysis, and reporting of randomized controlled trials.

Knowledge, Skills, and Abilities:

Strong understanding of clinical trial design principles, including adaptive designs.
Ability to effectively communicate complex statistical analyses and concepts to non-statisticians in non-technical language.
Ability to balance scientific rigor with operational and business considerations in a fast-paced development environment.
Knowledge and extensive hands-on experience with CDISC methodologies and industry data standards.
Demonstrated ability to manage multiple priorities and timelines while delivering high-quality outputs.
Working knowledge of regulatory guidelines and expectations in pharmaceutical development; experience supporting regulatory interactions is a plus.
Programming experience in SAS is required; experience in R is a plus.
Familiarity with real-world evidence and observational research methodologies (e.g., causal inference) is a plus.
Prior experience supporting clinical development programs in acute or chronic pain indications is a plus.
Understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry.

Benefits

Medical, Prescription, Dental, Vision Coverage
Flexible Spending Account & Health Savings Account with Company match
Employee Assistance Program
Mental Health Resources
Disability Coverage
Life insurance
Critical Illness and Accident Insurance
Legal and Identity Theft Protection
Pet Insurance
Fertility and Maternity Assistance
401(k) with company match
Flexible Time Off (FTO) and 11 paid holidays
Paid Parental Leave

Pay Transparency

The base pay range for this role is $102,000 to $140,000 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered.

The consultant will partner closely with cross-functional stakeholders to facilitate Quality by Design (QbD) activities, guide risk-based quality discussions, and develop clear, structured documentation that supports clinical trial quality and regulatory expectations. Candidates located in the Boston area with availability for occasional onsite workshops and working sessions are strongly preferred.

Key Responsibilities

• Lead and support Quality by Design (QbD) risk management activities across clinical development programs.
• Facilitate cross-functional workshops focused on clinical quality, critical-to-quality factors, and risk-based decision making.
• Identify, assess, and prioritize clinical trial risks while partnering with stakeholders to develop practical mitigation strategies.
• Translate workshop discussions and stakeholder input into well-organized quality documentation, including risk assessments, mitigation plans, and supporting governance materials.
• Apply Good Clinical Practice (GCP) principles and risk-based quality management methodologies to strengthen clinical trial oversight and execution.
• Support quality governance activities that promote proactive risk management, study quality, and inspection readiness.
• Collaborate effectively with Clinical Operations, Quality, and other cross-functional teams to drive alignment and consistency across the development program.

Qualifications

• Strong background in Clinical Quality Assurance with extensive knowledge of Good Clinical Practice (GCP).
• Hands-on experience with Quality by Design (QbD) methodologies and risk-based quality management within clinical development.
• Demonstrated success facilitating cross-functional workshops and building consensus among diverse stakeholders.
• Excellent documentation skills with the ability to convert complex discussions into clear, structured quality and risk management deliverables.
• Strong communication, organizational, and stakeholder management skills.
• Experience supporting clinical quality governance and risk management within biotechnology, pharmaceutical, or CRO environments is required.

Our client is a global organization focused on advancing novel therapies for patients with rare diseases, with a clinical pipeline spanning multiple stages of development and therapeutic areas including immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Bringing a collaborative, project-driven structure, the organization is building a forward-looking team dedicated to delivering treatments that make a meaningful impact worldwide. Utilizing three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy, the company continually refines ways in which products can address unmet medical needs and help patients lead full lives.

Currently they are seeking a Principal Biostatistician to provide statistical leadership for clinical development programs. In this role, you will lead components of statistical contribution to clinical development programs, implement statistical strategies for clinical trials and regulatory submissions within the program and will be accountable for statistical deliverables. It’s a fantastic opportunity to become a part of a stable and growing group with a focus on innovation. 

Responsibilities:

• Provide input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
• Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation
• Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan.
• Support Biostatistics interactions with regulatory authorities (e.g. FDA, EMA, PMDA)
• Be responsible for interpreting analysis results and ensuring reporting accuracy
• Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables to ensure quality.
• Be accountable for the TFL/CDISC package for study report and regulatory submission
• Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations

Qualifications:

• PhD or MS in Biostatistics, Statistics
• PhD 4+/ MS 6+ years or relevant work experience in the pharmaceutical industry and/or CRO
• Experience either managing a CRO, or having worked in a CRO
• Experience providing statistical leadership at a study level
• Demonstrated statistical contribution in facilitating and optimizing clinical development

Our client is a clinical-stage biotechnology company focused on developing innovative therapies for patients with serious central nervous system (CNS) disorders. Their mission is to advance transformative treatments that address significant unmet medical needs and improve the lives of patients and their families. As they continue to progress our clinical programs, they are seeking a strategic and hands-on Senior Director, Biostatistics to join their growing team.

Position Summary
The Senior Director, Biostatistics will provide statistical leadership across the clinical development programs and play a critical role in advancing our assets through key development and regulatory milestones. Reporting to senior clinical development leadership, this individual will serve as the lead statistician for clinical studies, providing expertise in trial design, statistical methodology, analysis planning, data interpretation, and regulatory submissions.

This role is ideal for an experienced biostatistics leader who thrives in a fast-paced biotech environment, enjoys working cross-functionally, and is comfortable rolling up their sleeves to support both strategic and operational activities. The successful candidate will have extensive experience supporting regulatory submissions and managing external CRO partners while contributing to overall development strategy.

Key Responsibilities

• Serve as the statistical lead across clinical development programs, providing strategic and technical leadership from study design through regulatory submission.
• Lead the development and review of study protocols, statistical analysis plans (SAPs), randomization specifications, TLF shells, clinical study reports, and regulatory submission documents.
• Provide statistical expertise for Phase 1, Phase 2, and Phase 3 clinical studies.
• Collaborate closely with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Medical Writing, Regulatory Affairs, and Pharmacovigilance teams.
• Oversee and manage CROs and external statistical programming vendors to ensure high-quality deliverables, timeline adherence, and regulatory compliance.
• Support interactions with regulatory agencies, including preparation for FDA meetings and responses to health authority questions.
• Guide endpoint selection, sample size calculations, estimand strategies, interim analyses, and overall statistical methodology.
• Review and interpret clinical study results and communicate findings to cross-functional teams and executive leadership.
• Ensure compliance with CDISC standards, ICH guidelines, and regulatory expectations.
• Contribute to clinical development plans, target product profiles, and overall program strategy.
• Support due diligence activities, investor communications, and corporate presentations as needed.
• Help establish and refine biostatistical processes and standards appropriate for a growing biotechnology company.

Qualifications
Required

• PhD in Statistics or Biostatistics.
• Minimum of 10 years of biostatistics experience within the pharmaceutical, biotechnology, or CRO industry.
• Significant experience serving as lead statistician for clinical development programs.
• Demonstrated success supporting NDA, BLA, and/or other major regulatory submissions.
• Strong understanding of FDA, EMA, and ICH regulatory requirements.
• Experience overseeing CROs and external statistical programming resources.
• Knowledge of CDISC standards, including SDTM and ADaM.
• Experience supporting Phase 2 and Phase 3 clinical trials.
• Strong communication, leadership, and influencing skills.
• Ability to work effectively in a lean, fast-moving biotech environment where flexibility and hands-on involvement are essential.

Preferred

• Prior experience in CNS, psychiatry, neurology, neurodegenerative diseases, or other neuroscience therapeutic areas.
• Experience supporting FDA meetings and regulatory interactions.
• Familiarity with adaptive designs, Bayesian methodologies, or innovative clinical trial approaches.
• Previous people leadership and mentoring experience.
• Experience working in small or emerging biotechnology companies.

Senior Director, Quantitative Pharmacology

Our client is seeking a director/senior director to head the Quantitative Pharmacology group within its Translational Medicine group in Princeton, NJ. The incumbent will report into the Vice President of Preclinical Development and Translational Medicine. The Quantitative Pharmacology group is responsible for the oversight over drug development aspects related to clinical pharmacology and pharmacometrics of clinical development candidates, working in close collaboration with nonclinical and clinical functional areas. This team works with all therapeutic areas within their Development Division. They are seeking a highly qualified individual to lead the group. Candidates must have a strong background in quantitative drug development and a desire to work collaboratively across different functional areas, as well as with external vendors and partners.

Success depends on the integrity, knowledge, imagination, creativity, skill, diversity and teamwork of the people in the group. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of the global team, you will collaborate with talented and dedicated colleagues across the Development Division while developing and expanding your career.

Primary Responsibilities:

• Key member of a product development team, contributing to the advancement of novel chemical entities bringing a quantitative perspective into strategic development to support continued investment
• Provide insight and leadership on pharmacokinetic aspects of clinical trials and programs and its application in development strategy
• Drive the implementation of pharmacometric principles and practices
• Development and execution of model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulations, and quantitative systems pharmacology (QSP) modeling
• Provide pharmacometric support for programs through the worldwide marketing application filing including supportive registration documents and presentations
• Provide clear, timely communication and interpretation of study results to functional area experts and governance/senior management
• Contribute to assessment of internal and external opportunities
• Interface broadly with key functions including discovery sciences, preclinical development groups, toxicology, clinical operations, drug metabolism, regulatory affairs, and late-stage clinical research
• Mentoring and/or supervision of junior staff to perform above duties and support career development

Qualifications:

• 5+ years of postdoctoral experience in quantitative pharmacology/pharmacometrics in the biotech and/or pharmaceutical industry
• Prior experience in the development and application of quantitative methods in drug development
• Strong background in population PK modeling, exposure response modeling and analysis, and developing statistical and mechanistic models for drug development
• Proven track record in clinical research and background in biomedical research
• Demonstrated record of scientific scholarship and achievement, willingness to work collaboratively across different therapeutic areas.
• Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential

Education:

• PhD in a quantitative science (e.g., statistics, mathematics, engineering, physics, computer science)

Our client is a global organization focused on advancing novel therapies for patients with rare diseases, with a clinical pipeline spanning multiple therapeutic areas and stages of development. Bringing a collaborative, project-driven structure, the organization is building a forward-looking team dedicated to delivering treatments that make a meaningful impact worldwide.

Currently they are seeking an Associate Director, Biostatistics to provide statistical leadership for clinical development programs. In this role, you will develop and implement statistical strategies for clinical trials and regulatory submissions, contributing to study design, data analysis, and reporting. This position offers strong visibility and requires close collaboration with cross-functional teams as well as interactions with regulatory agencies both in the U.S. and internationally. It’s a fantastic opportunity to become a part of a stable and growing group with a focus on innovation. 

Responsibilities

• Lead the full scope of Biostatistics activities for a clinical development program within a therapeutic area.
• Define statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions.
• Influence and contribute to clinical development plans and collaborate with cross-functional teams for governance reviews.
• Lead statistical strategy for study planning and execution as a member of the Study Executive Team and Clinical Development Team.
• Provide quantitative evaluation supporting clinical trials, regulatory submissions, and related documentation.
• Provide statistical thought partnership for innovative study design and clinical development plans, including Go/No-Go criteria and probability of technical success calculations.
• Plan and oversee program-wide statistical analyses and ensure the quality and timely delivery of interim and final results, including integrated analyses for submissions.
• Represent Biostatistics in interactions with regulatory authorities such as the FDA, EMA, and PMDA.
• Interpret analysis results and ensure accuracy in study reports and regulatory documents.
• Manage outsourcing operations or collaborate with internal statistical programmers within the program.
• Ensure the quality and timeliness of deliverables from CROs or functional service providers.
• Support or lead improvement initiatives within the department, organization, or broader pharmaceutical industry.
• Prepare abstracts, posters, oral presentations, and written reports to communicate results of clinical programs and studies to internal and external stakeholders.

Qualifications

• PhD or MS in Biostatistics, Statistics, or a related field
• PhD with 7 years of experience or MS with 9 years of experience in drug development
• Experience providing statistical leadership at the compound or indication level
• Demonstrated expertise in facilitating and optimizing clinical development strategies across early, late, or full development phases
• Experience supporting regulatory submissions
• Experience interacting with major regulatory authorities preferred
• Experience working with CROs or managing internal statistical deliverables preferred
• Demonstrated track record of innovation preferred

Core Competencies

• Familiarity with regulatory guidance and regulatory interactions
• Broad knowledge of clinical development processes
• Ability to work collaboratively and provide leadership in a matrix environment
• Strong written and verbal communication skills in English
• Good working knowledge of SAS and/or R
• Expertise across a range of statistical methodologies
• Experience applying innovative or creative statistical methods for clinical data analysis
• Familiarity with CDISC standards, statistical programming, and data standards

Location: Fully Remote

Our client is an established pharmaceutical company with a concentration in the therapeutic areas of CNS and Oncology. They are currently seeking an Executive Director, Clinical Data Science to shape and drive strategy across their global clinical development portfolio and to integrate statistical rigor with modern ML approaches. The role will define and lead global Clinical Data Science strategy, embedding advanced analytics, AI, and machine learning across the clinical development lifecycle. The ED will be responsible for driving innovation in trial design, disease modeling, biomarker discovery, imaging analytics, and precision medicine, with the goal of accelerating development timelines and improving decision quality. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards. Please have the following skills and background:

o Ph.D. in Biostatistics OR MS in Biostatistics in combination with a PhD in Bioinformatics, or related computational sciences.

o Deep expertise in statistical methods and their application in clinical trials, especially late phase trials.

o Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics.

o Recognized thought leader in at least one Data Science discipline (e.g., AI/ML modeling, precision medicine) and experience in applying either AI, Machine Learning and/or Precision Medicine to clinical trials

o Proven experience presenting at external forums and influencing regulatory authorities.

o Strong people leadership experience in a Clinical Trials Data Science setting.

o Prior research experience in Neurology, particularly Alzheimer’s disease biomarkers (plasma, CSF, imaging), is strongly preferred.

If you possess the above, please share your CV!

Contact: Susan Devine, Director - sdevine@penfieldsearch.com