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Manager Statistical Programming

$110k - $140k

Selby Jennings

Location: New Jersey (Hybrid - 3 days onsite) Salary: $110,000-$140,000 + bonus + benefits Overview We're currently partnered with a growing, mid-sized biotechnology organization is seeking a Manager, Statistical Programming to support clinical development programs and lead statistical programming activities across multiple studies. This individual will play a key role in delivering high-quality programming outputs for regulatory submissions while acting as a technical expert within the biometrics function. Key Responsibilities Serve as the technical lead and project manager for statistical programming deliverables across multiple clinical studies Oversee the development and validation of analysis datasets, tables, listings, and figures (TLGs) to support regulatory submissions and publications Collaborate cross-functionally with Biostatistics, Data Management, Clinical Operations, and Medical Writing to ensure alignment on study deliverables and timelines Represent Statistical Programming at study team and clinical development meetings Review key study documents including SAPs, CRFs, data management plans, and database specifications Develop and maintain SAS programs, macros, and utilities to support study- and product-level analyses Provide guidance on complex programming tasks and contribute to internal standards, SOPs, and best practices Interface with external CROs and vendors , ensuring quality and timely delivery of outsourced programming work Qualifications Bachelor's degree (or higher) in Statistics, Computer Science, Mathematics , or related discipline 5+ years of experience in statistical programming within a clinical development environment Strong expertise in SAS programming , with working knowledge of CDISC standards (SDTM, ADaM) Experience generating outputs to support regulatory submissions (FDA/EMA) Familiarity with R and/or Python is a plus Proven ability to work in a cross-functional, fast-paced environment and manage competing priorities Understanding of the drug development lifecycle across various phases #J-18808-Ljbffr

Vacancy posted 5 days ago
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