Executive Director , statistician Job at A mid-sized biopharmaceutical company, Cambridge, MA

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  • A mid-sized biopharmaceutical company
  • Cambridge, MA

Job Description

Our client, a mid-sized biopharmaceutical company, is seeking an Executive Director, Biostatistics to provide strategic leadership across a portfolio of neuroscience clinical programs. This individual will drive statistical strategy, trial design, and regulatory engagement from early development through registration, partnering closely with cross-functional teams to support high-quality, data-driven decision-making. This role reports to the Head of Biostatistics within the Quantitative Sciences organization.

Key Responsibilities

  • Lead statistical strategy across clinical programs, ensuring rigor and consistency from early development through submission.
  • Partner with Clinical and cross-functional leaders on trial design, endpoint strategy, and overall development planning.
  • Support global regulatory activities, including NDA/BLA submissions and interactions with agencies (FDA, EMA, PMDA).
  • Oversee quality and integrity of statistical deliverables and key study documents.
  • Apply innovative methods (e.g., adaptive designs, Bayesian approaches) to enhance development efficiency.
  • Build and lead a high-performing biostatistics team.

Qualifications

  • PhD in Statistics/Biostatistics (15+ years) or MS (18+ years) with relevant industry experience.
  • Strong track record leading statistical strategy across multiple programs and development stages.
  • Deep expertise in clinical trial design and modern statistical methodologies.
  • Experience supporting global regulatory submissions and health authority interactions.
  • Proven people leadership and ability to manage resources across programs.

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