Reports To: VP of Clinical Development

Position Summary

Prime Medicine is seeking an experienced Senior Director, Biometrics to serve as the senior biostatistics leader for the organization while providing strategic and operational leadership for the broader Biometrics function, including Clinical Data Management, in support of our gene editing clinical programs.

This individual will provide statistical expertise across Prime’s clinical portfolio, including input on study design, protocol development, dose-escalation strategy, interim analyses, regulatory interactions, and submission planning. In parallel, the individual will build and lead an integrated Biometrics function by providing strategic oversight and line management of Clinical Data Management while partnering closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, Translational Medicine and other functions.

This role requires both strategic vision and hands-on oversight, particularly in a lean, fast-moving biotech environment.  Although responsible for the broader Biometrics function, this position is first and foremost a senior biostatistics leadership role requiring deep expertise in clinical trial design, statistical methodology, regulatory interactions, and quantitative decision-making across clinical development.  This is a high visibility role with significant influence on clinical development decisions.

Key Responsibilities

Biometrics Strategy & Leadership

• Provide overall biometrics leadership across Prime Medicine’s clinical programs, spanning:
• Biostatistics
• Data Management
• Statistical programming (via vendors)
• Define and implement biometrics strategies appropriate for early- and mid-stage gene therapy development, including:
• Study design and statistical approaches
• Endpoint selection and estimands
• Data standards and quality frameworks
• Serve as the primary biometrics representative on cross-functional program and study teams.

Lead Biostatistician Responsibilities

Function as the lead statistician across Prime's clinical development portfolio, providing scientific and strategic statistical leadership from protocol concept through regulatory submission.

• Provide strategic input into:
• Clinical trial design
• Sample size and power considerations
• Randomization and statistical analysis plans (SAPs)
• As needed, data extraction and compilation for publications and external presentation activities
• Review, approve, and oversee key statistical deliverables, including:
• SAPs
• Interim and final analyses, including supporting SRC and DMC outputs
• Clinical Study Reports (statistical sections)
• Support regulatory interactions by contributing to:
• IND/CTA submissions
• Health authority briefing packages
• Responses to regulatory questions related to study design and analyses

Data Management Oversight

Provide strategic leadership and line management for the Clinical Data Management function, ensuring close integration between data management and statistical activities.

• Oversee data management strategy and execution, including:
• CRF design and database build
• Data cleaning, validation, and lock
• Data standards (e.g., CDISC/SDTM/ADaM expectations)
• Ensure data quality, integrity, and inspection readiness across all clinical programs.
• Provide input into protocol development and study start-up activities to ensure efficient data collection
• Partner with Clinical Operations and vendors to proactively identify and resolve data-related risks.

Vendor Management & Operational Execution

• Lead vendor selection, onboarding, and governance for biometrics-related CROs and service providers.
• Provide active oversight of vendor performance, timelines, quality, and budgets.
• Ensure clear scopes of work, deliverable expectations, and communication pathways.
• Act as the escalation point for biometrics-related issues and drive timely resolution.

• Ensure biometrics deliverables are aligned with clinical, regulatory, and program objectives.
• Contribute to inspection readiness activities and support audits as needed.

Function Building & Future Growth

• Establish scalable biometrics SOPs/processes, standards, and best practices appropriate for a growing organization.
• Contribute to longer-term planning for internal capability development, including future team growth as the pipeline expands.
• Mentor and guide internal team members or matrixed contributors as applicable.

Qualifications

Required

• Advanced degree in Statistics, Biostatistics, Mathematics, or a related quantitative field.
• 10+ years of experience in biometrics (biostatistics and/or data management) within biotech or pharmaceutical development.
• Demonstrated experience supporting clinical development programs, including regulatory submissions, ideally with experience supporting early-phase (FIH) through later stage programs.
• Experience serving as the lead statistician for clinical studies and regulatory submissions.
• Strong understanding of clinical trial design, statistical principles, and data management practices especially in rare disease and/or gene and cell therapies.
• Proven experience leading biometrics through CRO/vendor models.
• Deep familiarity with regulatory expectations (FDA, EMA, ICH) related to biometrics.
• Experience leading or managing Clinical Data Management is strongly preferred but is not required.
• Excellent leadership, communication, and cross-functional collaboration skills.