Director/ Senior Director, Biostatistics

About the role

The Director/Senior Director of Biostatistics provides scientific and strategic guidance for one or more clinical development projects within Cogent Biosciences. 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 own the statistical strategy and execution for assigned oncology programs, translating complex development plans into actionable statistical frameworks. This position requires leadership in key decision-making processes to safeguard data integrity and drive program success. You will report directly to the VP, Biometrics and act as a statistical thought partner for cross-functional teams. The role demands a proactive approach to solving challenging methodological problems in a dynamic biotechnology setting.

Key facts

What you'll do

Provide statistical leadership as the primary statistician for assigned oncology clinical programs from protocol design through database lock and regulatory submission.

Contribute to the development and refinement of clinical development strategies, including protocol design, endpoint selection, and estimands definition.

Perform complex sample size calculations, power analyses, and interim design considerations for adaptive and group sequential trials.

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

Lead the preparation of statistical sections for New Drug Applications (NDA), Biologics License Applications (BLA), and other regulatory submissions.

Collaborate with Data Management to ensure data quality, integrity, and compliance with CDISC standards such as SDTM and ADaM.

Oversee statistical analysis performed by Contract Research Organizations (CROs) and external consultants to ensure timely delivery of high-quality outputs.

Partner with Clinical Operations to optimize study timelines, monitor progress, and resolve operational or analytical challenges.

Work closely with Medical and Clinical Science teams to align statistical methodologies with clinical rationale and unmet medical needs.

Support cross-functional interactions with Statistical Programming to ensure reproducibility and efficiency in analysis workflows.

Contribute to the advancement of Biometrics capabilities, standards, and best practices across the growing Cogent Biosciences organization.

Evaluate and recommend appropriate statistical methods for handling missing data, sensitivity analyses, and multiplicity issues.

Ensure adherence to International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and industry standards in all statistical activities.

Act as a statistical consultant to non-statistical team members, explaining complex concepts in clear and actionable terms.

Drive the successful integration of data across studies to support broader clinical development objectives.

Requirements

Ph.D. in Biostatistics or Statistics or an MS degree with equivalent experience.

Possess at least 8 years of relevant experience in the pharmaceutical or biotechnology industry for a Ph.D. holder; or at least 10 years for an MS holder.

Demonstrate strong prior experience in oncology clinical development and drug development programs.

Have a proven track record as the lead statistician for one or more clinical development projects, including pivotal studies.

Bring experience in supporting regulatory submissions such as NDA, BLA, or MAA and interactions with health authorities.

Show a strong understanding of ICH GCP and general awareness of industry practices, standards, and guidelines.

Exhibit proficiency in SAS programming for clinical data analysis.

Demonstrate knowledge of additional statistical software such as EAST, nQuery, or PASS is advantageous.

Have hands-on experience with CDISC standards, including the creation and review of SDTM and ADaM datasets.

Exhibit excellent communication, leadership, and cross-functional collaboration skills to work effectively with diverse teams.

Nice to have

Prior experience in supporting health authority interactions and regulatory submissions is preferred.

Experience in building and enhancing Biometrics processes and best practices in a growing biotech environment is desirable.

Practical notes

This is a full-time position.

Travel may be required as part of the role.

Visa sponsorship may be available for qualified candidates.

Candidates must meet the stated qualifications as hard requirements.