Senior Manager, Statistical Programming - Główny Programista
Core
Lead statistical programming teams to design, develop, and implement technical solutions for integrating, analyzing, and reporting clinical data to support regulatory approval and market acceptance of pharmaceutical products.
Role type
Senior Manager, Statistical Programming
Builds
Clinical data analysis datasets, regulatory submission components (e.g., ADaM, TFLs), and electronic submission packages
Domain
Pharmaceutical / Clinical Data Management / Biostatistics
Required skills
SAS, R, CDISC standards (SDTM, ADaM), relational databases, clinical trial methodology, regulatory guidance, statistical programming, upstream data processing, downstream deliverables
Preferred skills
Management experience supervising technical professionals
Technologies
SAS, R, XML, Pinnacle 21, MS Office
Responsibilities
Provide programming leadership and support to clinical project teams and vendors; Develop and validate complex programs and utilities; Lead electronic submission preparation and review; Develop unambiguous programming specifications; Review planning documents to align with project objectives; Identify and lead process improvement opportunities
Seniority
Senior, hands-on IC with management responsibilities