Senior Manager/Associate Director, Statistical Programming
Development – Development Operations /
Who We Are
Cogent Biosciences is a publicly traded 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 (SM), 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. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.
Reporting to the Senior Director, Statistical Programming, the candidate will provide statistical programming execution of clinical trials, collaborate with statisticians and data managers to ensure high quality and timely statistical programming deliverables, ensure compliance to internal standards and SOPs. This position will serve as the in-house statistical programming expert and provide consultation to other functions.
The Senior Manager/Associate Director, Statistical Programming will lead statistical programming deliverables and milestones from study start-up to regulatory submission and oversees CRO programming activities. The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally. You will ensure that statistical programming activities are performed to the highest quality standards and timely deliverables.
This role partners with key study/program team members to develop and implement project plans for assigned studies, ensuring the functional activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing statistical programming activities with vendors to support the flawless execution of a clinical trial. Develops study level quality and oversight plans, ensures adherence and consistent execution across the data flow. Collaborates to ensure alignment of study operational plans with program goals. Accountable to update and manage study timelines, statistical programming deliverables.
- Serve as the main point of contact with statistical programming vendors; overseeing projects’ entire statistical programming efforts including but not limited to:
- Develop and validate of technical programming specifications and programs.
- Generation of SDTM and ADaM datasets.
- Produce SAP specific tables, listings and figures.
- File all statistical programming related study documentation.
- Ensure programs and processes are developed, implemented and effectively administered.
- Accountable for development of timelines, project management of all end-to-end statistical programming deliverables in collaboration with cross functional team members and vendors on assigned studies.
- Act as the primary contact between statistical programming and clinical study management teams. Liaise directly with internal customers (Biostatistics, Clinical, Medical, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Leads and Project Management personnel).
- Ensure that out-sourced statistical programming tasks are performed according to GCP, approved SOPs, and protocol.
- Manage performance and quality issues with vendors and escalates internally when needed.
- Support study-level/drug program audit and inspection readiness activities as needed.
- Bachelor’s degree in a scientific discipline. Master’s degree or higher preferred.
- Minimum 6 years statistical programming 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 a demonstrated mastery of SAS/STAT procedures.
- Extensive experience and proven skills in use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles.
- Working knowledge of CDISC SDTM and ADaM standards to support statistical analysis, including generating analysis data listing, tables, and figures and create all files necessary to support electronic submissions in the eCTD format.
- Prior experience filing a BLA or NDA preferred
- Deep understanding of drug development and biopharmaceutical industry required.
- Proven ability to manage multiple, competing priorities.
- Experience overseeing outsourced clinical trials work.
- Strong, flexible and impactful communicator.
- Self-motivated with the ability to drive exceptional results/outcomes, even with aggressive timelines.
- Salary: $175,000 - $205,000
- Target Bonus: 15%
Exact compensation may vary based on skills, experience, and location.