Director/ Senior Director, Biostatistics

The Role

Serve as statistical lead for assigned oncology clinical programs, providing strategic and hands-on statistical leadership from early development through pivotal trials and regulatory submissions.

Provide statistical input into clinical development strategy, protocol design, endpoint selection, estimands, sample size calculations, interim analyses, and adaptive designs.

Develop and review statistical analysis plans, clinical study reports, regulatory documents, and responses to health authority questions.

Support NDA/BLA submissions and regulatory interactions with statistical expertise.

Oversee statistical activities performed by CROs and external consultants, ensuring high-quality and timely delivery of statistical outputs.

Collaborate closely with Clinical Development, Regulatory Affairs, Data Management, Clinical Operations, and Statistical Programming teams.

Contribute to building and enhancing Biometrics capabilities, processes, and best practices in a growing biotech environment.

Qualifications

• Ph.D. in Biostatistics or Statistics with at least 8+ years of experience in pharmaceutical or biotechnology industry; or MS with at least 10+ years of relevant experience.
• Strong oncology clinical development experience preferred.
• Experience as the lead statistician for one or more clinical development projects, including pivotal studies.
• Experience supporting regulatory submissions (NDA/BLA/MAA) and interactions with health authorities.
• Strong understanding of ICH GCP and general knowledge of industry practices and standards.
• Proficiency in SAS programming and other statistical software, including EAST, nQuery, or PASS.
• Experience with CDISC standards, including SDTM, ADaM, CDASH.
• Excellent communication, leadership, and cross-functional collaboration skills.

Pay

Director: $225,000 - $265,000
Sr. Director: $255,000 - $300,000

Benefits

• Competitive salary and bonus
• Ongoing stock awards
• Benefits package including:
• 100% medical, dental, and vision premiums
• Up to 75% of in-network deductibles funded
• 401(k) match with immediate vesting
• Generous paid time off
• 12 weeks of fully paid parental leave
• Paid family and medical leave for all employees regardless of location
• Company-paid short-term disability coverage for up to 20 weeks
• Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support

About the Role

Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.