Associate Director of Biostatistics

Job Summary

To support innovative clinical trial designs, the full-time Associate Director of Biostatistics will manage protocol development, statistical analysis planning, and regulatory submissions while collaborating with cross-functional teams across various locations.

Key Responsibilities

• Collaborates in the design of clinical trials and contributes to project development strategy
• Independently authors and reviews statistical analysis plans, clinical study reports, and other study-level documents
• Provides statistical support for health authority requests and presents analysis results clearly and transparently

Required Qualifications

• PhD with 6+ years or MS with 8+ years of experience in statistics, biostatistics, or a related field
• Proficiency in scientific computing/programming (SAS, R, or Python) for advanced statistical analysis
• Expertise in statistical/clinical trial methodology relevant to clinical development
• Strong understanding of the regulatory landscape and experience with regulatory interactions
• Demonstrated leadership and project management skills, with people management experience preferred