Senior Director, Statistical Programming
Who We Are:
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 patient's.
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) - both serious conditions driven by oncogenic KIT signaling. Bezuclastinib is currently being evaluated in multiple registration-directed trials across Non-Advanced SM (NonAdvSM), Advanced SM (AdvSM), and 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. The company 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 also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor, and the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting other serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.
Through its commitment to precision medicine and targeted innovation, Cogent Biosciences is working to transform the treatment landscape for patients with serious and underserved diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease. Our culture of inquisitiveness fuels continuous learning and innovation; we challenge assumptions, ask bold questions, and embrace a mindset of discovery to uncover transformative insights.
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.
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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
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