Associate Director, Statistical Programming
Celldex Therapeutics • Needham, MA2d • $153,616 - $199,501
Associate Director Statistical Programming Jobs
25 jobs found — updated daily
Statistical Programming Associate Director
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Associate Director, Statistical Programming
Celldex Therapeutics•Needham, MA
•$153,616 - $199,501
About The Position
The Associate Director, Statistical Programming is a senior-level leadership role at Celldex Therapeutics responsible for overseeing the statistical programming lifecycle for clinical trial and project work. The role provides technical leadership, project coordination, and cross-functional collaboration to ensure programming deliverables meet company, industry, and regulatory standards. It also supports in-house programming needs, including regulatory filings, ad hoc analyses, and publication requests.
Requirements
- Master of Science in Statistics or a related field.
- At least 8 years of SAS programming experience in the biotech or pharmaceutical industry.
- Experience as a lead programmer coordinating programming teams in support of multiple regulatory submissions.
- Experience managing people and projects.
- Proficiency with SAS Base, Macro, SQL, and Graph.
- Experience working with and managing external CROs or FSPs for programming deliverables.
- Familiarity with CDISC (SDTM/ADaM) standards and ability to adapt them for non-interventional data structures.
- Excellent communication skills and ability to work cross-functionally in a lean team environment.
Nice To Haves
- Working knowledge of R.
Responsibilities
- Lead or coordinate statistical programming activities for programmers assigned internally or externally to study and project work, mentor programmers in functional expertise and processes, and make study- or project-level programming decisions and recommendations.
- Comply with company, department, and industry standards and processes, including CDISC; ensure quality control and audit readiness of assigned deliverables and the accuracy and reliability of statistical analysis results.
- Oversee creation of CDISC-compliant submission-ready outputs, including SDTM and ADaM datasets, Tables, Listings and Figures (TFLs), and associated Define packages.
- Oversee external programming activities outsourced to CROs, ensuring quality, standard programming practices, validation, and documentation.
- Build and maintain effective working relationships with internal and external cross-functional teams, and contribute to the status of deliverables and critical programming considerations such as timelines, scope, and resource plans.
- Support in-house programming activities as needed, including regulatory filings, ad hoc analyses, and publication requests.
Benefits
- Annual discretionary bonus
- Long-term incentive
- 401(k) plan with employer contribution
- Health care and other insurance benefits for employee and family
- Paid holidays
- Vacation
- Sick days
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What This Job Offers
Job Type
Full-time
Career Level
Senior
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Common questions about Associate Director Statistical Programming careers and jobs.
Based on current job postings on Teal, the average Associate Director Statistical Programming salary in the US is approximately $175,000 per year, with a typical range of $150,000 to $200,000.
