Senior Director, Biostatistics

About the role

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. This person 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.

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.
• 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.
• About You
• 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 fo

Benefits

Additional Information

About Formation Bio 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 TrialSpark 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, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

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