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Role Description

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.

• 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

Qualifications

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related field
• 5+ years of SAS programming experience within pharmaceutical/biotech
• Strong understanding of statistical methods used in clinical trial analysis
• Knowledge of Good Programming Practices and GCP
• Preferred: Experience with R programming

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

Time Zone Requirements

• West Coast: ~6-hour overlap with China; flexibility for late afternoon/evening PST collaboration
• OR
• East Coast: ~6-hour overlap with EU; flexibility for early morning EST collaboration (approx. 5:00–11:00 AM EST)