3h ago

Director, Biostatistics - Late Phase

Redwood City, California, United States
full-timedirector Hybridoncology

Tech Stack

Description

You will serve as a lead statistician for late-stage oncology clinical programs, providing statistical leadership and strategic input to development plans, study design, and regulatory submissions. Collaborate cross-functionally to ensure accurate data analysis and presentation, and drive best practices within the Biostatistics function.

Requirements

  • Ph.D. or M.S. in Statistics/Biostatistics with 8+ years (Ph.D.) or 12+ years (M.S.) industry experience
  • Hands-on experience in design and analysis of late-stage oncology trials
  • Solid knowledge of ICH and regulatory requirements for clinical trials
  • Excellent verbal and written communication skills
  • Proficiency in SAS and/or R

Responsibilities

  • Lead statistician for clinical program(s) and studies in late-stage development
  • Provide statistical support and strategic input to clinical development plans and regulatory submissions
  • Collaborate on study design, protocol development, and statistical analysis plans
  • Plan and coordinate independent data monitoring committee (DMC) reviews
  • Drive department initiatives and best practices
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