Responsibilities

• Strategic Leadership: Lead and develop the Biostatistics team, fostering a high-performance culture aligned with Formation Bio’s mission and values. Provide mentorship and career development to ensure team growth and expertise.
• Statistical Strategy & Innovation: Drive statistical strategy across clinical development programs, incorporating optimal trial designs, simulation-based approaches, and AI/ML applications to enhance efficiency and decision-making. Guide clinical and regulatory strategies to optimize trial design and maximize the probability of success.
• Study Design & Execution: Provide expert statistical input into clinical study design, endpoint selection, analysis planning, and regulatory interactions. Explore innovative trial design options to identify the most effective clinical development strategy that aligns with business needs and optimizes decision-making. Ensure study designs are scientifically rigorous, operationally feasible, and aligned with regulatory expectations. Leverage AI-driven clinical trial automation to enhance study execution, optimize resource allocation, and improve trial efficiency.
• Regulatory & Cross-Functional Collaboration: Partner with Clinical, Data Science, Regulatory, and Business Development teams to support drug diligence, development and regulatory interactions, FDA briefing books, and submission-related activities. Represent Biostatistics in key regulatory meetings (e.g., FDA, EMA) to ensure statistical rigor in clinical development plans.

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