Senior Director, Biometrics

Key Responsibilities

• 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)
  • 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.