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.

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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.

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

HEOR Consultant

We are seeking a highly motivated and experienced Health Economics and Outcomes Research (HEOR) Consultant to support a growing clinical development pipeline. This individual will be responsible for developing and executing HEOR strategies to demonstrate the value of pipeline assets, inform strategic decision-making, and support future market access efforts.

Key Responsibilities

• Develop and implement comprehensive HEOR strategic evaluations of pipeline programs, including unmet needs assessments from a payer perspective.
• Design, implement, and oversee economic models, real-world evidence (RWE) studies, and patient-reported outcome (PRO) assessments to support asset value propositions.
• Collaborate cross-functionally with Clinical Development, Regulatory, Medical Affairs, Market Access, and Commercial teams to integrate HEOR insights into clinical development plans.
• Engage with external stakeholders, including payers, key opinion leaders (KOLs), patient advocacy groups, academic institutions, and industry partners to understand evidence requirements and optimize data-generation strategies.
• Develop key value messages and integrated evidence plans aligned with market access, medical, and commercial strategies.
• Stay current on evolving HEOR methodologies, regulatory requirements, HTA requirements, and market access landscapes.
• Support the design, execution, and dissemination of HEOR studies.
• Lead the development of value dossiers (GVD, AMCP) and health technology assessment (HTA) submissions to support global reimbursement and market access efforts.

Qualifications

• Doctoral degree (PhD, DrPH, ScD) in health services research, epidemiology, health economics, or a related field with 2+ years of relevant professional experience; or
• Master’s degree with 4+ years of relevant professional experience in pharmaceutical/biotech, consulting, healthcare, academic, or research settings.
• Experience leading complex products and early-phase HEOR strategy supporting pipeline development.
• Strong understanding of HEOR methodologies, including economic modeling, RWE generation, and PRO development.
• Extensive knowledge of the global regulatory, HTA, and pricing & reimbursement landscape and its relationship to drug development.
• Strong analytical, strategic, and project management skills.
• Publication record in peer-reviewed journals and/or conference presentations.
• Excellent written and verbal communication and presentation skills.
• Ability to work independently and effectively across cross-functional teams.

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

This is a hands-on role at the intersection of Data Science, Biostatistics, Statistical Programming, and Clinical Data Management.

The ideal candidate combines strong programming and technical development skills with an understanding of clinical studies and the ability to build practical solutions that improve how teams’ access, analyze, visualize, and work with clinical data.

This individual will support ongoing studies while also helping build the technical infrastructure, automation, and reusable tools that enable a growing Biometrics organization to work more efficiently. The successful candidate will be forward-thinking, collaborative, and comfortable bringing new ideas and modern approaches to a highly cross-functional environment.

Primary Responsibilities

• Develop data science solutions and analytical tools to support clinical studies and broader Biometrics initiatives.
• Design and build dashboards and data visualizations that enable effective clinical data review and decision-making.
• Develop reusable tools, workflows, and infrastructure that can be leveraged by Statistical Programming, Biostatistics, Data Management, and other team members.
• Build and maintain automated workflows using GitHub and GitHub Actions.
• Create automated quality checks and validation processes to improve code quality and reliability.
• Develop workflows that support code review, testing, and deployment of analytical applications and tools.
• Work with databases and data sources to support data integration, access, analysis, and visualization.
• Apply R and SAS to clinical data and analytical challenges, selecting the appropriate technology based on the specific use case.
• Utilize Python when it provides the most effective solution to a particular technical or analytical problem.
• Support the development and maintenance of interactive analytical applications using R Shiny.
• Partner closely with Biostatistics, Statistical Programming, Data Management, and other cross-functional stakeholders to understand study needs and develop effective technical solutions.
• Identify opportunities to automate manual processes and introduce more efficient and innovative ways of working.
• Establish and promote effective Git/GitHub workflows, version control, and collaborative development practices.
• Help less experienced team members adopt modern programming, version control, automation, and application development practices.
• Contribute ideas and technical expertise as the organization's Data Science and clinical analytics capabilities continue to grow.

Qualifications

• Bachelor's or Master's degree in Data Science, Statistics, Biostatistics, Computer Science, or a related quantitative field.
• Significant experience working in Data Science, Statistical Programming, Clinical Analytics, or a related technical function within the pharmaceutical, biotechnology, or clinical research environment.
• Advanced programming experience in R and SAS.
• Experience building and maintaining R packages.
• Strong hands-on experience with Git and GitHub.
• Demonstrated experience creating and using GitHub Actions to automate testing, validation, or other development workflows.
• Experience developing analytical applications, dashboards, and data visualizations, including R Shiny.
• Experience working with databases and integrating data into analytical workflows.
• Strong understanding of software development and collaborative coding practices, including version control, code review, testing, and automation.
• Ability to develop reusable technical solutions and infrastructure that can be leveraged by other team members.
• Experience working with clinical study data and supporting study teams.
• Strong cross-functional communication skills with the ability to work effectively across Biostatistics, Statistical Programming, Data Management, and other clinical functions.
• Ability to operate independently in a small, growing organization while remaining highly collaborative.

Preferred Experience

• Working knowledge of Python and the ability to apply it selectively when it is the appropriate solution.
• Experience building infrastructure, frameworks, or reusable tools that enable other programmers, statisticians, or data scientists to work more efficiently.
• Experience automating development and quality-control processes.
• Experience helping teams adopt Git/GitHub, R Shiny, automation, or other modern development practices.

Key Success Factors
The successful candidate will be:

• Hands-on and technically strong. Able to personally build solutions rather than only direct the work of others.
• Forward-thinking. Brings ideas and looks for better, more efficient ways of solving problems.
• Practical. Selects technology based on the problem rather than forcing every problem into the same technical solution.
• Collaborative. Works effectively across clinical and technical functions and communicates well with colleagues with varying levels of technical expertise.
• A builder. Comfortable joining a growing organization and helping establish the tools, infrastructure, and ways of working that will support the team as it scales.
• Self-directed. Able to identify needs, propose solutions, and drive work forward while collaborating closely with the broader team.

This position serves as a critical bridge between Biostatistics and Clinical Data Management (CDM), ensuring the development of CRFs and the delivery of high-quality clinical data. Additionally, this position will play an important role in establishing SOPs and programming standards, and modernizing statistical reporting with open-source tools.

• Provide programming leadership and oversee study to compound-level programming deliverables in collaboration with the lead biostatistician and cross-functional teams.
• Serve as the lead programmer to review the SAP, Data Presentation Plan, and Table Shells to align with project objectives and ensure clarity and completeness of programming assumptions and requirements.
• Lead programming team to produce and/or validate SDTM, ADaM, and TLF for CSR and regulatory requests, publication needs, and ad-hoc analyses.
• Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence.
• Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications.
• Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports.
• Develop company tools, such as R packages, macros, and interactive data dashboards (e.g., with Shiny), to enhance the efficiency and capacity of the Statistical Programming team.
• Develop robust programs to create define.xml. Lead the NDA eSubmission package preparation.

• Under the guidance of the Head of Statistical Programming and Compound Lead, implement innovative strategies and technologies to enhance programming processes.
• Working with the manager, establish Statistical Programming standards and deploy programming strategies, specifications, and programmed analyses.
• Proactively plan, implement, and identify issues/risks and provide remediation strategies to improve programming capability.

• Master’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field.

• Minimum of 6 years of statistical programming experience in the pharmaceutical, biotech, or CRO clinical trial environment.
• Advanced SAS and R programming skills, with experience using Git for version control required. Extensive hands-on experience with SDTM, ADaM, and TLF programming.
• Python programming experience is desirable.
• Proficient knowledge in the implementation of CDISC standards (SDTM, ADaM) and regulatory submission requirements.
• Good knowledge of the drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology.
• Broad expertise in statistical programming and in developing computing strategies.
• In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience with their implementation in clinical trials.
• Knowledge of data validation, define.xml generation using Pinnacle 21.
• Results-oriented, with proven problem-solving skills and a strong interest in continued learning.
• Excellent communication and collaboration skills, with the ability to work closely with cross-functional teams.
• Experience managing outsourced programming activities and overseeing deliverables from CROs and contractors.
• Adaptable and able to thrive in a fast-paced, startup environment while managing multiple priorities effectively.
• Experience with regulatory audits and inspections (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage.

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

Position Summary

The Associate Director, Clinical Data Standards and Governance is a hands-on subject-matter expert and standards owner who leads the design, implementation, and lifecycle governance of clinical data standards across the enterprise data value chain — from protocol concept and collection through acquisition, tabulation, analysis, and regulatory submission. This role is the technical backbone of the Enterprise Clinical Data Standards & Regulatory Submission Readiness program, translating governance council decisions into concrete, adopted standards content and driving the metadata, controlled terminology, and validation infrastructure that makes those standards usable at study level.

The incumbent personally develops and maintains the standards library (CDASH/eCRF, SDTM, ADaM, Define-XML/SDRG/ADRG, controlled terminology) and the governance mechanics that keep it current — version control, change/exception workflows, regulatory surveillance, and compliance metrics — while partnering across CDM, Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Quality, and IT/Data Engineering to ensure standards are consistently authored once and reused everywhere. This is an individual-contributor leadership role: the person in this seat is expected to do the standards work directly, chair or drive technical working groups, and set technical direction, not simply oversee others doing it.

The role also carries responsibility for compliance with applicable corporate and divisional policies and procedures, and for maintaining an active, credible presence in the external CDISC standards community.

Key Responsibilities

Standards Content Ownership

• Own and maintain the enterprise standards library across all five layers of the data architecture: Collection (CDASH, eCRF library, edit checks), Acquisition (labs, ECG, imaging, eCOA, biomarker, digital health, external transfer specifications), Tabulation (SDTM domains, sponsor conventions, mappings, controlled terminology, Define-XML, cSDRG), and Analysis (ADaM, analysis metadata, ADRG, TLF interfaces).
• Maintain a complete and in-depth understanding of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulation on electronic submission of data; keep abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management, and data warehousing.
• Author and publish sponsor SDTM/ADaM implementation conventions, controlled terminology mappings, and eCRF/CDASH specifications that are reusable across studies and therapeutic areas.
• Demonstrate extensive understanding of CDASH and SDTM standards and concepts; critically review eCRF designs to ensure compatibility and conformance with CDASH/SDTM standards, proactively recognizing and correcting design flaws.
• Demonstrate extensive understanding of SDTM, controlled terminology, and common coding dictionaries; review SDTM conformance mapping specifications and proactively correct flaws, and provide input and CDISC expertise to cross-functional activities such as mapping of source data to SDTM.
• Lead impact assessments and version releases when CDISC, regulatory, or internal business requirements change, ensuring controlled, documented rollout with defined effective dates and training.
• Maintain Define-XML, SDRG, and ADRG templates and conventions to support consistent, submission-ready documentation across the portfolio.

Governance, Process & Compliance

• Ensure personal and team compliance with all applicable corporate and divisional policies and procedures governing clinical data standards and their implementation.
• Serve as a core technical member (and, where appropriate, chair) of Tier 3 standards working groups (Collection, External Data, SDTM & Submission, ADaM & Analysis, Technology & Automation), preparing proposals for review by the Clinical Data Standards Governance Council.
• Operate the standards change-control and exception/deviation workflow end to end: intake, functional SME review, council approval, publication, and study-team implementation.
• Maintain the standards charter, governance council terms of reference, SOPs, and work instructions that keep standards mandatory rather than optional guidance, and keep RACI/decision rights current across CDM, Biostats, Programming, Clinical Ops, Regulatory, Quality, and IT.
• Run regulatory surveillance for evolving CDISC, FDA, and ICH data standards requirements and translate changes into prioritized updates to the standards library.
• Represent Clinical Data Standards during audits and regulatory inspections; ensure inspection-ready documentation and full traceability from source data to submission.

Technology, Metadata & Automation

• Own and continuously improve the metadata repository, including release management, version control, lineage/traceability controls, and automated validation rules; manage libraries of CDISC-related metadata, terminology, and related standards within the repository, and provide governance oversight to the Manager, Data Standards to ensure consistency of metadata.
• Demonstrate knowledge of SDTM/ADaM validation rules and the associated Define.xml requirements; execute standard validation tools and appropriately interpret results, collaborating with other functions to resolve identified issues and ensuring any unresolved issues are appropriately documented (e.g., in the FDA's Data Reviewer's Guides).
• Partner with IT/Data Engineering and Biometrics to standardize system interoperability across EDC, external data platforms, and downstream tabulation/analysis tools.
• Drive adoption of automated validation and standards-compliance tooling, and identify AI-enabled use cases (e.g., automated mapping, spec generation, QC) that increase reuse and reduce cycle time.
• Maintain the standards-compliance dashboard and report enterprise-level adoption, quality, speed, and readiness metrics to program leadership and the Governance Council.

Adoption, Enablement & Cross-Functional Partnership

• Develop and deliver role-based training, study implementation playbooks, and office hours / community-of-practice sessions to drive consistent standards adoption across study teams and CROs.
• Effectively mentor peers, the Manager, Data Standards, Senior Data Standards Analysts, and Data Standards Analysts on data standards concepts and functional operations; train new Data Standards Analysts on the processes and systems used to manage and implement standards.
• Define and enforce CRO/vendor data standards requirements; review vendor deliverables (transfer specifications, mapping specs) for conformance.
• Act as the standards subject-matter expert in cross-functional forums, providing guidance to study teams, Biostatistics, Statistical Programming, and CRO partners on standards interpretation and implementation; diplomatically and persuasively represent the interests of the Data Standards group in cross-functional initiatives.
• Capture pilot lessons learned and feed continuous-improvement recommendations back into the standards library and governance processes.

External Standards Engagement

• Maintain an external reputation as a clinical data standards expert and represent the organization in the broader CDISC community.
• Coordinate consolidated review comments from the Data Standards group and Statistical Programming for applicable CDISC standards released for public review.
• Submit at least one abstract per year for presentation at a CDISC Interchange.

Success Measures
Performance in this role is assessed against enterprise standards KPIs spanning adoption (e.g., studies and vendor transfers on standard), quality (deviations, critical findings, repeat defects), speed (CRF build cycle time, mapping/spec reuse, DB lock-to-submission-ready timeline), and readiness (first-pass QC, traceability completeness, inspection-ready documentation, exception turnaround).
Qualifications

• Bachelor's or Master's degree in Life Sciences, Computer Science, Health Informatics, or a related discipline.
• 10+ years of progressive experience in clinical data management or clinical data standards, with demonstrated ownership of enterprise-level standards content (not solely study-level execution).
• Deep, hands-on expertise in CDISC standards — CDASH, SDTM, ADaM, controlled terminology — and Define-XML/SDRG/ADRG authoring.
• Working knowledge of clinical data collection and acquisition technologies (EDC/Rave, RTSM, eCOA, external/vendor data transfers) sufficient to define standards and specifications, though this role is standards-focused rather than systems-administration-focused.
• Experience building or operating a metadata repository, standards library, or comparable governance infrastructure, including version control and validation frameworks.
• Demonstrated experience authoring SOPs, work instructions, and governance charters, and operating change-control or exception workflows in a regulated environment.
• Solid understanding of GCP, ICH, 21 CFR Part 11, and global regulatory expectations as they relate to data standards, traceability, and submission readiness (NDA, BLA, MAA).
• Proven ability to lead or contribute to cross-functional governance bodies and technical working groups, influencing without direct authority across CDM, Biostatistics, Programming, Clinical Operations, Regulatory, Quality, and IT.
• Strong written and verbal communication skills, with experience producing governance documentation, training materials, and dashboards for varied audiences up to senior leadership.
• Comfort operating as an individual-contributor expert who personally produces standards deliverables, balanced with the leadership presence to drive adoption across

The Principal Biostatistician will collaborate closely with cross-functional Medical Affairs stakeholders on evidence-generation activities, including those incorporating real-world data and evidence. The role will provide statistical guidance on clinical and lifecycle management initiatives, advise on analytical strategies, and recommend appropriate methodological approaches to support integrated evidence generation and informed decision-making.

Essential Functions

• Work collaboratively with other members of the Medical Affairs team to develop and provide scientifically sound analyses that answer questions to support and enhance publications and knowledge of company products.
• Contribute to publication objectives including timelines, statistical and analytical requirements for publications and projects.
• Develop, design, and oversee or perform post-hoc analyses of existing databases and meta-analyses as needed and appropriate
• Support clinical development biostatistics with exploratory analyses necessary for submissions and regulatory queries.
• Review publications, marketing materials, and education and training materials that contain clinical data and product claims
• Stay informed with data being generated in current clinical development programs
• Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results as necessary
• Collaborate and provide statistical support to the HEOR group in relevant areas including HTA and NTAP submissions.
• Develop real world evidence strategies utilizing real-world data assets to design and execute RWE research projects, including the development of protocols and statistical analysis plans, in collaboration with epidemiology and RWE leadership team.
• Stay current with new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and other professional development activities.

Minimum Requirements

• Master’s degree with >2 years of experience; OR PhD in statistics, mathematics or a related discipline with a statistical focus.
• Proficient in drug development regulations pertinent to statistical analysis
• Proficient SAS & R programming skills
• Understanding of CDISC SDTM and ADAM models and standards is preferred, but not required.
• Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.
• Able to work in a fast-paced, flexible, team-oriented environment.

We are partnering with a growing biotech organization seeking a Clinical Data Manager/Data Analyst to support ongoing and upcoming clinical programs across multiple therapeutic areas.

This role will sit within a highly collaborative clinical development team and is ideal for a hands-on, analytical Clinical Data Manager who enjoys digging into the data, identifying trends or issues proactively, and developing creative solutions to improve data quality and study execution. The client is seeking someone resourceful and technically curious — not just process-oriented — with the ability to independently explore datasets, generate meaningful reports, and surface potential issues early.

The ideal candidate will bring a blend of traditional clinical data management expertise along with strong data review, querying, and analytical skills. Experience with R, SQL, SAS, or other data interrogation and reporting tools is highly desirable.

Key Responsibilities

• Support clinical data management activities across studies from start-up through database lock
• Perform hands-on data review and exploratory analysis to identify data trends, inconsistencies, missing data patterns, and potential study risks
• Develop custom reports, listings, and data visualizations to support proactive data cleaning and study oversight
• Utilize R, SQL, SAS, or similar tools to query, analyze, and troubleshoot clinical datasets
• Partner with CROs and vendors to ensure high-quality, timely data delivery
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Medical, and Safety teams on data review strategies and issue resolution
• Contribute to development and review of key deliverables including:
• Data Management Plans (DMPs)
• eCRF design and completion guidelines
• Edit checks and query logic
• User Acceptance Testing (UAT)
• Data review plans and cleaning processes
• Support ongoing query management and ensure data integrity, consistency, and inspection readiness
• Assist with implementation of data standards, reporting enhancements, and process improvements
• Work independently to investigate data anomalies and recommend practical solutions in a fast-paced biotech environment

Qualifications

• BS in a scientific, technical, or clinical discipline
• Approximately 5–8 years of clinical data management experience within biotech, pharma, or CRO environments
• Strong hands-on experience reviewing and interrogating clinical trial data
• Experience using R, SQL, SAS, or other querying/reporting tools to analyze clinical data and generate custom reports
• Experience with EDC systems such as Medidata Rave, Oracle, or Veeva
• Working knowledge of CDISC standards (SDTM/ADaM) and downstream data usage
• Experience supporting Phase II and/or III clinical trials; CNS experience is a plus
• Exposure to CRO/vendor oversight
• Understanding of clinical data structures and dictionaries including MedDRA and WHODrug
• Strong critical thinking and problem-solving skills with the ability to work independently
• Resourceful, proactive, detail-oriented, and comfortable operating in a dynamic biotech environment
• Strong communication and cross-functional collaboration skills

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.

We are seeking a Senior Regulatory Submission Lead to support a critical BLA submission across Module 2 and Module 5. This 1 year contract role will provide hands-on submission execution and cross-functional coordination to ensure regulatory content is aligned, complete, and ready for filing.

• Coordinate BLA submission activities across Module 2 and Module 5, including timelines, deliverables, and submission readiness.
• Support preparation and review of submission content, including CSRs, appendices, ISS, ISE, and related regulatory documentation.
• Ensure clinical and biometrics outputs are incorporated into accurate, regulatory-ready submission content.
• Manage submission documentation, QC, version control, and workflows within Veeva Vault.
• Support eCTD publishing activities and FDA-facing submission needs.
• Identify gaps, track dependencies, and help maintain submission timelines.

• 7+ years of experience supporting regulatory submissions within the life sciences industry.
• Advanced scientific or clinical training preferred (PhD, PharmD, or MD), with prior ophthalmology experience strongly preferred.
• Hands-on BLA submission experience with strong knowledge of FDA Module 2 and Module 5 requirements.
• Experience independently coordinating submission activities from planning through filing, including FDA interactions and regulatory communications.
• Hands-on experience using Veeva Vault to support regulatory submissions, including document management, workflows, QC, and submission readiness, with a strong understanding of eCTD processes and publishing activities.

Success in This Role
The successful candidate will quickly step into an active BLA submission environment, coordinate across functions, and help ensure Module 2 and Module 5 deliverables remain aligned and submission-ready through filing.

Hourly Rate: $120-$175/hour

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

This is an onsite role based in the Bay Area.

• Apply extensive technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases.
• Use initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design.
• Work collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials.
• Work with project team members on developing clinical protocol.
• Review CRFs, CRF edit checks and CRF completion guidelines.
• Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated.
• Review ADaM specifications and verify primary and secondary efficacy endpoints.
• Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
• Effectively manage CRO to ensure high-quality deliverables within timeline and budget.
• Oversee programming of ADaMs and TLFs for the study.
• Responsible for one or more studies with concurrent tasks and timelines.
• Participate in the validation/QC of key study endpoint analysis and submission deliverables.
• Apply appropriate regulatory guidelines to the projects.
• Guide the successful completion of major programs, projects and/or functions.
• Develop technical and/or business solutions to complex problems.
• Identify and implement methods, techniques, procedures, and evaluation criteria to achieve results.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.

Please Have:

• MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
• PhD in related discipline and a minimum of 5 years of related experience; or,
• Experience in Oncology and study Phases I-III highly preferred.
• Experience in Biotech/Pharmaceutical industry preferred.
• Experience with managing CROs in the conduct of clinical trials.
• Experience with statistical applications and clinical data management procedures in the conduct of clinical trials.
• Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.
• Knowledge of appropriate regulations, industry standards and guidance documents.
• Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs and companies collaborating with Exelixis.
• Developed/reviewed SDTM/ADaM specifications
• Strong SAS programming knowledge.
• Complete understanding and wide application of technical principles, theories, concepts, and techniques.
• Have good general knowledge of other related disciplines.

This is onsite role based in the Bay Area.

About the Role:

• Provide leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases.
• Apply sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.
• Develop and/or applies statistical theories, methods and software.
• Partner in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data.
• Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
• Represent biostatistics function in interactions with institutional review boards, ethics committees, and health agencies.
• Work with department head to develop and implement department standards and practices.
• Direct the statistical design, conduct, and analysis of clinical trials in all phases.
• Review protocols and case report forms for soundness of trial design.
• Review and or author statistical analysis plans for all phases of a trial.
• Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
• Direct the development, validation and summary of integrated safety and efficacy summaries.
• Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements.
• Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development.
• Contribute to the development of Requests-for-Proposals.
• Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
• Responsible for all statistical oversight within a therapeutic area.

Please have:

• MS/MS degree in Statistics/Biostatistics and 10 years’ industry experience or PhD and 7 years.
• Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to Oncology trials.
• Developed/reviewed SDTM/ADaM specifications.
• Excellent knowledge of FDA/EU statistical guidelines.
• Experience in state-of-the-art data organization and statistical analyses using statistical software such as: R and SAS.
• Understanding of other disciplines such as data management, clinical operations, clinical science, regulatory affairs and drug safety.
• Project management and contract negotiation with outside vendors.