Senior Statistical Programmer
Job Summary
Managing multiple clinical study deliverables, the remote Senior Statistical Programmer will generate SDTM and ADaM specifications, develop and validate SAS and/or R programs, and ensure compliance with FDA regulations and ICH guidelines on a 12-month renewable contract.
Key responsibilities:
- Generate SDTM and ADaM specifications, datasets, and reviewer's guides
- Develop and validate SAS and/or R programs for clinical study reports and regulatory submissions
- Collaborate with project leads to manage timelines and quality standards across multiple studies
Required qualifications:
- BS/BA in computer science, mathematics, statistics, or related field with 6+ years of experience, or a Master's with 4+ years, or a PhD with 2+ years
- Advanced SAS skills (Base, Stat, Macro, Graph) required; R knowledge is a plus
- Strong command of CDISC standards (SDTM, ADaM) and define.xml
- Familiarity with 21 CFR Part 11 and FDA electronic submission guidelines
Complete Job Description
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