Senior Director of Biostatistics

Senior Director of Biostatistics

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Formation Bio is a tech and AI‑driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio – founded in 2016 as Trial Spark Inc.

– has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in‑licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.

• Our Vision for AI in Pharma
• Our Current Drug Portfolio
• Our Technology & Platform

Formation Bio is seeking a highly skilled and experienced Senior Director, Biostatistics to join our dynamic team. This critical role will report to the Head of Biometrics and will be responsible for leading and developing the biostatistics team and strategy, driving impactful statistical initiatives, and leveraging biostatistics to advance our drug development processes. The Senior Director, Biostatistics will play a key role in shaping innovative trial designs, supporting regulatory strategies, and ensuring high‑quality statistical contributions across clinical development.

They will also collaborate cross‑functionally to integrate advanced analytics, data‑driven decision‑making, and AI applications into our development programs to improve efficiency and increase the probability of success.

• 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.
• Operational Excellence: Establish and refine statistical workflows, SOPs, and best practices to improve efficiency, quality control, and compliance with industry standards.
• Data‑Driven Decision‑Making: Champion data‑driven approaches and quantitative decision‑making frameworks, integrating scenario analyses and statistical trial simulations to optimize clinical trial execution and strategic development plans.
• External Engagement: Stay at the forefront of industry trends and regulatory expectations, representing Formation Bio in scientific discussions, conferences, and collaborations.
• Vendor & CRO Management: Oversee and…