Senior Director, Statistical Programming

Senior Director, Statistical Programming 1 week ago Be among the first 25 applicants Cogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically defined diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease and offer meaningful hope to patients. The company’s lead therapeutic candidate, bezuclastinib, is a highly selective tyrosine kinase inhibitor designed to potently target KIT D816V and other mutations in KIT exon 17. These mutations are known drivers of systemic mastocytosis (SM) and advanced gastrointestinal stromal tumors (GIST). In July 2025, Cogent announced that its registration‑direct SUMMIT trial in patients with NonAdvSM achieved statistical significance across all primary and key secondary endpoints, and the company is on track to file its first New Drug Application for this patient population by the end of 2025. Cogent also remains on track to announce top‑line results for its APEX trial in patients with AdvSM in the second half of 2025 and for its PEAK trial in patients with GIST by the end of 2025. The company has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor and is developing a portfolio of novel targeted therapies to help patients fight other serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα, and KRAS. The Role This is an exciting opportunity to contribute to the growth of the Biometrics organization. The Senior Director, Statistical Programming provides expert support for statistical programming deliverables and milestones from study start‑up through regulatory submission, working closely with internal teams and external vendors. The ideal candidate is an experienced statistical programmer who can work independently, collaborate effectively across functions, and ensure programming activities are completed with high quality and efficiency. You will play a key role in driving process consistency, ensuring compliance, and supporting timely, high‑quality data deliverables. In this role, you will contribute to functional initiatives such as vendor coordination, systems integration, and process improvement. You will also assist in developing and maintaining SOPs and best practices to support high‑quality programming deliverables and compliance with internal and external standards. You will collaborate with study and program team members to implement project plans, ensure vendor activities meet expectations, and provide programming support for clinical trials. Responsibilities include developing study‑level quality and oversight plans, tracking timelines and deliverables, and aligning programming activities with program goals. Responsibilities Reporting to the VP, Biometrics, responsibilities include but are not limited to: Serve as a primary contact for statistical programming vendors; support coordination of programming deliverables, including: Development and validation of technical programming specifications and programs Generation of SDTM and ADaM datasets Production of SAP‑specific tables, listings, and figures Management and documentation of all statistical programming activities Implementation of process and technology improvements to enhance efficiency and quality Contribute to the development and maintenance of SOPs and guidelines for statistical programming and ensure adherence across projects Coordinate end‑to‑end programming deliverables in collaboration with cross‑functional team members and vendors Collaborate closely with internal stakeholders (Biostatistics, Clinical, Medical, Regulatory) and external partners (Full‑Service and Functional Service Providers) Ensure outsourced programming activities are performed according to GCP, approved SOPs, and study protocols Monitor vendor deliverables and quality, escalating issues when needed Support study‑ and program‑level audit and inspection readiness activities Qualifications BS/BA/MA/MS with 12+ years or PhD with 8+ years of statistical programming experience in biotech/pharmaceutical companies or CROs Extensive programming project experience in biotech/pharmaceutical companies or CROs Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a Windows environment, with demonstrated mastery of SAS/STAT procedures Strong experience with CDISC SDTM and ADaM standards and familiarity with eCTD submission requirements Demonstrated success in managing programming deliverables across multiple studies and vendors Deep understanding of drug development and the biopharmaceutical industry Proven ability to manage multiple, competing priorities in a dynamic environment Excellent communication, collaboration, and organizational skills Self‑motivated and results‑oriented, with the ability to meet tight timelines Advanced experience with: Constructing technical programming specifications Relational databases Good Clinical Practices (GCP) Good Programming Practices (GPP) 21 CFR Part 11 Standards Integrated summary safety/efficacy analyses Safety data and coding dictionaries (MedDRA and WHODD) Salary Range $250,000 – 280,000 USD Target Bonus: 25% Exact compensation will vary based on skills, experience, and location. Our Offer To You To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance‑based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time‑off, a 401(k) plan, and commuter/parking benefits. Our Locations Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on‑site parking and gym facilities in the building. Boulder, CO: We have just moved into our new state‑of‑the‑art Research Facility in the fast‑growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full‑time in this location and we are proud to call this the home of Cogent’s discovery research organization. Equal Opportunity Employer 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. #J-18808-Ljbffr