Senior Director of Biostatistics

Senior Director, Biostatistics - Formation Bio. This role reports to the Head of Biometrics and is 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 manage statistical vendors, including consulting statisticians and CROs, ensuring high-quality statistical deliverables and compliance with GCP and regulatory standards.

• Ph.D. in Biostatistics, Statistics, or a related field with 10+ years of experience in biostatistics within the pharmaceutical or biotech industry, statistical consulting firms, or CROs supporting clinical development.
• Proven experience leading biostatistics teams and strategies within clinical development.
• Deep expertise in statistical trial designs, adaptive designs, Bayesian methods, and simulation-based approaches for both early and late-stage development.
• Strong understanding of regulatory guidelines for drug development, including FDA and EMA requirements for statistical practice, regulatory submissions, and health authority interactions.
• Experience in quantitative decision-making frameworks to support internal Go/No-Go decisions.
• Demonstrated track record of leading statistical contributions to progress assets from diligence, early development through regulatory submissions and approvals.
• Ability to collaborate cross-functionally with Clinical, Data Management, Programming, Data Science, Regulatory, and other teams.
• Strong problem-solving skills with the ability to balance scientific rigor with operational efficiency.
• Excellent communication skills, with the ability to convey complex statistical concepts into actionable insights for non-statisticians, senior management, and regulatory agencies.
• Proficiency in SAS, R (S-Plus), and statistical software for sample size calculations (e.g., East, PASS, NQuery). Expert R programming skills are a plus.
• Passion for innovation, AI-driven methodologies, and data-driven decision-making in clinical development.

Formation Bio is a tech and AI-driven pharma company focused on accelerating drug development and clinical trials. Formed in 2016 as Trial Spark Inc., the company partners with 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…