
Head of Biostatistics
Warman O'Brien, South San Francisco, CA, United States
Small Innovative Biotechnology company (CNS / Gene therapy)
Role overview
The Head of Biostatistics leads statistical strategy across the clinical development pipeline, partnering with Clinical and Regulatory teams to deliver high-quality, regulatory-ready data that drives asset progression and approvals.
Key Responsibilities
- Strategic Leadership: Define and lead statistical strategy, study design, analyses, and innovative methodologies across early- to late-stage trials.
- Regulatory Partnership: Serve as the senior biostatistics lead for submissions and health authority interactions (FDA/EMA).
- Functional Leadership: Build and lead the biostatistics function, overseeing CROs, setting standards, and developing high-performing teams.
Requirements
- Ph.D. or MS degree in Biostatistics or related discipline with extensive industry and leadership experience in Statistics, Biostatistics
- Experience in neurology/neuroscience clinical trials, including trial design and execution, with a strong background in late-stage clinical trials and in trials for disease modifying therapies preferred
- Parkinson's/Alzheimer's and Gene therapy is a bonus
- Extensive knowledge of clinical trial development and statistical methodologies
- Proven leadership experience managing Global teams and operating in a matrix environment
What to do next:
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