Senior Director, Biostatistics

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.