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.

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
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.

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.

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.

• 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.

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.

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.