Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com No 3rd party candidates
We are seeking a highly experienced Statistical Programmer to lead programming activities across global clinical studies. This role operates beyond executional programming, with responsibility for oversight of CRO deliverables, validation of outputs, and end-to-end accountability for statistical programming packages.
Key Responsibilities
Lead statistical programming activities across global studies
Serve as primary programming lead in collaboration with Biostatistics
Develop, review, and validate SDTM and ADaM datasets in accordance with CDISC standards
Review specifications and proactively challenge inconsistencies in protocols, SAPs, and dataset definitions
Validate program outputs and ensure accuracy, quality, and regulatory compliance
Provide oversight and guidance to CRO partners, consolidating and communicating feedback effectively
Manage timelines, delivery packages, and milestone commitments Contribute to continuous improvement of programming processes and standards
Core Requirements
Strong expertise in CDISC standards, including ADaM and SDTM
Demonstrated experience reviewing specs and ensuring high-quality, submission-ready deliverables