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Niche SAS/CDISC regulatory expertise and seniority reduce applicant density and competition.
Role requires domain-specific clinical trial, regulatory and CDISC experience, limiting cross-industry transferability.
Explicit 8+ years, SAS certification, and regulatory/CDISC mandates create strict screening filters.
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Lead end-to-end statistical programming for multiple clinical studies, serving as primary client contact.
Develop and validate SAS programs for SDTM and ADaM datasets, as well as Tables, Listings, and Graphs (TLGs) for regulatory submissions.
Collaborate with cross-functional teams to deliver study outputs compliant with FDA, PMDA, EMA standards, and maintain project documentation per SOPs.
Minimum 8+ years experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role.
Proficient in Base SAS, SAS/STAT, Macro Language, and advanced SAS programming including PROC SQL, PROC REPORT; SAS Certified mandatory.
Experience in CDISC standards: SDTM, ADaM; knowledge of regulatory guidelines including E6, E3, E9, 21 CFR Part 11 is required.
Education: Bachelor of Science in Basic Science or equivalent; Master’s in Statistics or related science preferred. R programming experience and AI tool usage are pluses, not mandatory.
Strong experience preparing datasets and outputs for NDA regulatory filings with detailed knowledge of clinical trial methodologies and coding dictionaries (WHO, COSTART, ICD-9, MedDRA).
Demonstrated ability to lead multiple clinical protocols simultaneously with a focus on automation, performance optimization, and use of AI-enhanced programming.
Skilled in both SAS and R programming environments including use of Git-based version control and data reporting frameworks in clinical research context.