Job description
Senior Director, Biostatistics
Location: Emeryville, CA
Company Overview:
A clinical-stage biopharmaceutical company focused on developing cell therapies using advanced T cell engineering.
Role Summary:
Lead the Biostatistics team, collaborating with stakeholders and CROs to oversee and support clinical studies. Ensure high-quality, timely, and budget-compliant delivery of biostatistical analyses for studies and programs.
Key Responsibilities:
- Provide strategic leadership in biostatistics for global clinical development, establishing biostatistical standards.
- Design studies, perform power calculations, and execute statistical analyses, contributing to study reports and decision-making.
- Guide data collection, design, and analysis for global studies, including DSMB meetings.
- Oversee statistical aspects of clinical studies, regulatory submissions, and interactions with regulatory agencies.
- Prepare clinical study documentation, ensuring compliance with industry standards (e.g., CDISC).
- Collaborate across functions to support clinical trials, development, and commercialization strategies.
Requirements:
- Ph.D. in Biostatistics, Statistics, or a related field.
- 10+ years of experience in clinical trial biostatistics, with expertise in regulatory interactions, preferably in immunology and neurology.
- Proficiency in R, SAS, and experience in generating TFLs.
- Familiarity with complex statistical methods, including adaptive Bayesian design.
- Strong communication skills and attention to detail.
Compensation:
- Salary: $240,000 - $300,000 annually, plus bonus, benefits, and stock options.