Senior Director, Statistical Programming jobs in United States
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Cogent Biosciences · 2 months ago

Senior Director, Statistical Programming

positionWaltham, MA
timeFull-time
remoteHybrid
seniorityDirector/Executive
money$250K/yr - $280K/yr
date8+ years exp

Cogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically defined diseases. The Senior Director, Statistical Programming will provide expert support for statistical programming deliverables and milestones, ensuring high-quality and efficient programming activities while collaborating with internal teams and external vendors.

BiotechnologyHealth CareMedicalTherapeutics
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

SAS/BaseCDISC SDTMADaM standardsStatistical programmingClinical PracticesRelational databasesTechnical programming specificationsCommunicationCollaboration skillsOrganizational skillsSelf-motivatedResults-oriented

Required

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
Advanced experience with relational databases
Advanced experience with Good Clinical Practices (GCP)
Advanced experience with Good Programming Practices (GPP)
Advanced experience with 21 CFR Part 11 Standards
Advanced experience with integrated summary safety/efficacy analyses
Advanced experience with safety data and coding dictionaries (MedDRA and WHODD)

Benefits

Competitive pay
Performance-based bonus
Stock options
Insurance coverage (health, dental, life, and disability)
Competitive time-off
A 401(k) plan
Commuter/parking benefits

Company

Cogent Biosciences

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Cogent Biosciences is a biotechnology company that develops therapies for solid cancer tumors.
dateFounded in 2014
location
Waltham, Massachusetts, USA
people-size51-200 employees
web-link
https://www.cogentbio.com

H1B Sponsorship

Cogent Biosciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (3)

Funding

Current Stage
Public Company
Total Funding
$1.6B
Key Investors
Commodore CapitalFairmount Funds ManagementSquare 1 Bank
2025-11-10Post Ipo Equity· $200M
2025-11-10Post Ipo Debt· $200M
2025-07-08Post Ipo Equity· $230M

Leadership Team

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Andrew Robbins
CEO and President
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A
Abb Hayden
Senior Vice President of Sales
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Recent News

GlobeNewswire
Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones for Bezuclastinib and Precision Therapies Portfolio
2026-01-12
Investing.com
Cogent Biosciences stock falls after multiple insider sales
2025-12-31
GlobeNewswire
Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in NonAdvanced Systemic Mastocytosis
2025-12-30
Company data provided by crunchbase