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Remote, 12-month renewable contractStatistical 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.