Senior Director of Biostatistics

Job Summary

Leading the Biostatistics function within therapeutic areas, the full-time Senior Director of Biostatistics will provide statistical input for development strategies, oversee study design and analyses, and ensure high-quality deliverables while managing resources in a global organization.

Key Responsibilities

• Manages functional or project budgets and allocates resources according to development needs across multiple compounds
• Directs and guides statisticians to ensure timely and high-quality deliverables while maintaining compliance with processes and standards
• Contributes to Clinical Development Plans and represents the company in interactions with global regulatory agencies

Required Qualifications

• PhD or MS in statistics, biostatistics, or a related scientific field with at least 12 years of experience in clinical trials or drug development
• Proficiency in scientific computing/programming (SAS, R, or Python) and advanced statistical analysis
• Extensive experience in preparing for and participating in global regulatory agency interactions
• Demonstrated leadership abilities with at least 5 years of management experience preferred
• Expertise in statistical methodology applicable to clinical development and regulatory alignment