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Senior Director, Biometrics

Prime Medicine· Clinical
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Cambridge, MA$263k - $292kfull-timePosted 3mo ago

About the role

Senior biostatistics leader responsible for strategic and operational leadership of Prime Medicine's Biometrics function, including Clinical Data Management, supporting gene editing clinical programs with input on study design, regulatory interactions, and submission planning.

Responsibilities

  • Provide overall biometrics leadership across Prime Medicine’s clinical programs, spanning Biostatistics, Data Management, and Statistical programming (via vendors).
  • Define and implement biometrics strategies for early- and mid-stage gene therapy development, including study design and statistical approaches, endpoint selection and estimands, and data standards/quality frameworks.
  • Serve as the primary biometrics representative on cross-functional program and study teams.
  • Function as lead statistician across the clinical development portfolio from protocol concept through regulatory submission.
  • Provide strategic input into clinical trial design, sample size/power, randomization and SAPs, and data extraction/collection for publications/external presentations.
  • Review, approve, and oversee SAPs, interim/final analyses, and statistical sections of Clinical Study Reports.
  • Support regulatory interactions contributing to IND/CTA submissions, health authority briefing packages, and responses to regulatory questions.
  • Provide strategic leadership and line management for Clinical Data Management, ensuring integration with statistical activities.
  • Oversee data management strategy including CRF design, database build, data cleaning/validation/lock, data standards (CDISC/SDTM/ADaM).
  • Ensure data quality, integrity, and inspection readiness; input into protocol development and startup activities; partner with Clinical Operations and vendors to resolve data-related risks.
  • Lead vendor selection, onboarding, governance for biometrics CROs/providers; oversee vendor performance, timelines, quality, budgets; establish SOWs and communication pathways; act as escalation point for biometrics issues; contribute to inspection readiness and audits as needed.
  • Establish scalable biometrics SOPs/processes; participate in long-term planning for internal capability development and team growth; mentor internal team members.

Qualifications

  • Advanced degree in Statistics, Biostatistics, Mathematics, or related quantitative field.
  • 10+ years of experience in biometrics (biostatistics and/or data management) within biotech or pharmaceutical development.
  • Experience supporting clinical development programs including regulatory submissions, ideally from early-phase (FIH) through later stage.
  • Experience serving as 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 not required.
  • Excellent leadership, communication, and cross-functional collaboration skills.

Skills

Required:BiostatisticsClinical Data ManagementRegulatory Submissions

Benefits

  • Total Rewards package including medical, dental, vision, life insurance, 401(k) match, and equity programs; generous paid time off, wellness days, and company-wide recharge breaks.
Last updated Sep 16, 2026. Interested? Apply on the company site.

About Prime Medicine

Delivering on the promise of Prime Editing

Prime Medicine™ was founded with a goal of transforming the lives of patients with debilitating diseases through the application of our groundbreaking Prime Editing platform and technology.

next- generation gene editingPrime Editinggene editingtherapeutic applications
Company profileWebsite

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