Senior Director, Biometrics

The role

The Senior Director, Biometrics will serve as the senior biostatistics leader and provide strategic and operational leadership for the Biometrics function, including Clinical Data Management. This person will provide statistical expertise across the clinical portfolio and lead an integrated Biometrics function in support of gene editing clinical programs.

What you will do

• Provide overall biometrics leadership across clinical programs including Biostatistics, Data Management, and Statistical programming.
• Define and implement biometrics strategies for study design, endpoint selection, and data standards.
• Serve as the primary biometrics representative on cross-functional program and study teams.
• Function as the lead statistician providing scientific and strategic leadership from protocol concept through regulatory submission.
• Provide strategic input into clinical trial design, sample size, randomization, and statistical analysis plans.
• Review and oversee statistical deliverables including SAPs, interim and final analyses, and Clinical Study Reports.
• Support regulatory interactions including IND/CTA submissions and health authority briefing packages.
• Provide strategic leadership and line management for the Clinical Data Management function.
• Oversee data management strategy, execution, and data quality.
• Lead vendor selection, onboarding, and governance for biometrics-related CROs and service providers.

Required qualifications

• 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.
• 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.
• Excellent leadership, communication, and cross-functional collaboration skills.

Nice to have

• Experience leading or managing Clinical Data Management

Benefits

• Medical
• Dental
• Vision
• Life insurance
• 401(k) match
• Equity programs
• Generous paid time off
• Wellness days
• Company-wide recharge breaks

About the company

Prime Medicine is a biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients using its proprietary Prime Editing platform.