Formation Bio · 5 hours ago
Senior Director of Biostatistics
New York, NY
Full-time
Hybrid
Director/Executive
$262K/yr - $340K/yr
10+ years expFormation Bio is a tech and AI driven pharma company focused on revolutionizing drug development. They are seeking a Senior Director of Biostatistics to lead the biostatistics team, drive statistical strategy, and support innovative trial designs to enhance drug development processes.
Artificial Intelligence (AI)BiotechnologyClinical TrialsHealth CareMedicalPharmaceutical
Responsibilities
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
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
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
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
Establish and refine statistical workflows, SOPs, and best practices to improve efficiency, quality control, and compliance with industry standards
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
Stay at the forefront of industry trends and regulatory expectations, representing Formation Bio in scientific discussions, conferences, and collaborations
Oversee and manage statistical vendors, including consulting statisticians and CROs, ensuring high-quality statistical deliverables and compliance with GCP and regulatory standards
Qualification
Required
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
Company
Formation Bio
Formation Bio is a drug development company that strives to provide treatments to patients faster by reimagining clinical trials.
51-200 employees
H1B Sponsorship
Formation Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
Funding
Current Stage
Late StageTotal Funding
$528MKey Investors
Andreessen Horowitz
2024-06-26Series D· $372M
2021-09-30Series C· $156M
2018-10-15Series Unknown
Leadership Team
Benjamine Liu
CEO and Co-founder at Formation Bio
Linhao Zhang
Co-Founder
Recent News
BioWorld Financial Watch
2025-12-19
2025-12-16
2025-12-11
Company data provided by crunchbase