Senior Statistical Programmer

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 Virtual Vocations Inc