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 (EU and China exposure preferred)
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
Experience validating CRO programming deliverables
Ability to operate with increased performance accountability and ownership
Strong CRO-facing communication and collaboration skills
Proven ability to manage multiple global studies simultaneously
Qualifications
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related field
5+ years of SAS programming experience within pharmaceutical/biotech
Preferred: Experience with R programming
Time Zone Requirements
OR
