Prime Medicine
Senior Director, Biometrics
Cambridge, MA · Director · Full-time
Sponsorship not specified$263k-$292kDetected 9 hours ago
StatisticsVendor ManagementClinical TrialsFDA RegulatoryCRISPRExperimental DesignLeadershipCommunicationCollaborationBiostatisticsRegulatory Affairs
About the role
- Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients.
- Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung.
- For more information, please visit www.primemedicine.com.
Responsibilities
- 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.
- Clinical trial design
- Responses to regulatory questions related to study design and analyses
- CRF design and database build
- Partner with Clinical Operations and vendors to proactively identify and resolve data-related risks.
- Lead vendor selection, onboarding, and governance for biometrics-related CROs and service providers.
Requirements
- 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.
- 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.
- Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.
- Required
- Experience serving as the lead statistician for clinical studies and regulatory submissions.
- Deep familiarity with regulatory expectations (FDA, EMA, ICH) related to biometrics.
- Excellent leadership, communication, and cross-functional collaboration skills.
- The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).
- Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits-including medical, dental, vision, life insurance, a 401(k) match, and equity programs-along with generous paid time off, wellness days, and company-wide recharge breaks.
Nice to have
- Experience leading or managing Clinical Data Management is strongly preferred but is not required.
Skills
- Biostatistics
- Data Management
- Statistical programming (via vendors)
- 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.
Compensation
- $263,000 - $292,000 USD
Benefits
- Health authority briefing packages
Equal opportunity
- Prime Medicine is proud to be an equal opportunity employer.
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This listing is sourced directly from Prime Medicine's careers page and normalized into a canonical job model.