Role Summary
The Senior Director, Biostatistics will lead the biostatistics team and strategy, driving innovative statistical approaches to enhance clinical development. This role involves shaping trial designs, supporting regulatory strategies, and integrating data-driven decision-making to improve efficiency and success rates.
Responsibilities
- Lead and mentor the biostatistics team, fostering growth and collaboration
- Develop statistical strategies that incorporate innovative trial designs, simulations, and AI/ML applications
- Provide expert input on study design, analysis planning, and regulatory interactions
- Represent Biostatistics in regulatory meetings (FDA, EMA) and support submission activities
- Establish and improve statistical workflows, SOPs, and best practices
- Oversee CROs and external statistical vendors to ensure quality and compliance
Experience Required
- Ph.D. in Biostatistics, Statistics, or related field with 10+ years of industry experience
- Proven leadership in biostatistics strategy within clinical development
- Expertise in adaptive trial designs, Bayesian methods, and statistical simulations
- Strong understanding of regulatory guidelines (FDA, EMA) and submission requirements
- Excellent communication skills with the ability to translate statistical insights for diverse audiences
- Proficiency in SAS and R; expertise in AI-driven methodologies is advantageous
Salary based on experience between $250,000 and $340,000