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Niche CDISC/SAS expertise and seniority reduce applicant density despite strong employer brand.
Clinical trials and regulatory data standards create strong domain-specific barriers to cross-industry transferability.
Explicit years plus mandatory SAS, CDISC, SDTM/ADaM and regulatory experience increase screening rigidity.
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Lead and manage all statistical programming activities for clinical studies including data management, statistical analysis, and reporting to support regulatory submissions and post hoc analyses.
Collaborate with biostatistics, data management, clinical research, regulatory affairs, and external vendors to deliver high-quality programming results on time.
Develop and maintain SDTM and ADaM datasets, reporting deliverables, global standard macros, and contribute to improvement of programming processes and SOPs.
Bachelor’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field; Master’s degree preferred.
8+ years statistical programming experience with Bachelor’s degree OR 6+ years with Master’s degree in Biotech, Pharmaceutical, or health-related industry.
Proficiency in SAS Base, STAT, Graph, Macro languages.
Experience with CDISC standards including SDTM and ADaM; knowledge of FDA/ICH guidelines and 21 CFR Part 11 regulations.
Experienced leader capable of independently driving programming projects and managing internal teams and external vendors in a regulated environment.
Strong expertise in statistical programming for clinical development with practical understanding of regulatory submission requirements (e.g., eCTD).
Ability to collaborate effectively across global, cross-functional teams and contribute to process improvement and mentoring junior programmers.