Senior / Principal Analyst, Statistical Programming

SIMULSTAT INC • Remote, US • published 2026-09-22 10:42:51.161108

Description

**Remote, 12\-month renewable contract** **Statistical Programmer (Senior / Principal)** **Responsibilities:** * Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and define.xml files. * Develop and validate SAS and/or R programs for datasets, listings, tables, and graphs. Support clinical study reports, regulatory submissions, publications, and exploratory analyses. * Manage overlapping deliverables across multiple studies while meeting timelines and quality standards. * Collaborate with sponsor project leads to keep programs on track. * Apply FDA regulations, ICH guidelines, and GCP standards to clinical trial data reporting. **Qualifications:** * BS/BA in computer science, mathematics, statistics, or a related field with 6\+ years of biopharma/CRO statistical programming experience, or a Master’s with 4\+ years, or a PhD with 2\+ years. Advanced SAS (Base, Stat, Macro, Graph) required, R a plus. * Strong command of CDISC standards (SDTM, ADaM) and define.xml. * Familiarity with 21 CFR Part 11 and FDA electronic submission guidelines. * Strong communication and organizational skills.

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