Who We Are:
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.
The Role: The Director/Senior Director of Biostatistics provides scientific and strategic guidance for one or more clinical development projects. In this role, you will ensure the design, analysis, and interpretation of study data meet the highest standards of scientific rigor and regulatory compliance. You will collaborate closely with partner functions—including Medical, Clinical Science, Clinical Operations, Data Management, and Statistical Programming—to support study objectives, contribute to regulatory submissions, and help drive the success of clinical development programs. This position reports to the VP, Biometrics.
Responsibilities:
- 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.
Salary Range:
- Director: $225,000 - $265,000
- Sr. Director: $255,000 - $300,000
Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building.
Boulder, CO: Our Boulder location is home to Cogent’s discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline.
Our Offer To You
At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart. We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles. Our benefits also include a 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, and company-paid short-term disability coverage for up to 20 weeks. Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
Skills Required
- Ph.D. in Biostatistics or Statistics with at least 8+ years industry experience, or MS with at least 10+ years of relevant experience
- Experience as lead statistician for clinical development projects, including pivotal studies
- Experience supporting regulatory submissions (NDA/BLA/MAA) and interactions with health authorities
- Proficiency in SAS programming
- Proficiency with sample size and interim analysis software (EAST, nQuery, PASS)
- Experience with CDISC standards (SDTM, ADaM, CDASH)
- Strong understanding of ICH GCP and industry practices and standards
- Excellent communication, leadership, and cross-functional collaboration skills
- Strong oncology clinical development experience
What We Do
Cogent Biosciences is a biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling.
