Associate Director, Statistical Programming

Celldex Therapeutics•Needham, MA

2d•$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.