Senior Director of Biostatistics

Job not on LinkedIn

May 11

🗽 New York – Remote

Although this job is listed in New York, this company may be open to hiring remote in other states.

💵 $262k - $340k / year

⏰ Full Time

🟠 Senior

👔 Director

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Formation Bio

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Artificial Intelligence • Biotechnology • Pharmaceuticals

Formation Bio is a tech-driven, AI-native pharmaceutical company that is revolutionizing the drug development process. By leveraging a proprietary technology-driven platform, Formation Bio aims to bring new treatments to patients faster and more efficiently, addressing critical unmet patient needs across various therapeutic areas. The company acquires clinical-stage drugs from pharma, universities, and biotech sectors and develops them more efficiently, using AI and technology to navigate the traditional bottlenecks in drug development. With a focus on radical efficiency, safety, and quality, Formation Bio seeks to bridge the gap between scientific discovery and patient access to new treatments.

51 - 200 employees

🤖 Artificial Intelligence

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. • 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. • 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.

🎯 Requirements

• 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.

🏖️ Benefits

• equity • comprehensive benefits • generous perks • hybrid flexibility