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Tier-1 biotech brand, metro location, and mid-level (3yr) requirement balanced by niche CDISC/SAS specialization.
Highly domain-specific CDISC/SAS clinical trial expertise limits cross-industry portability.
Explicit 3+ years, mandatory SAS/CDISC skills and regulatory experience make filters stringent.
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Perform statistical programming activities to support data analysis of phase 1 to 4 clinical studies and regulatory submissions.
Create and validate SDTM, ADaM, and other analysis datasets including tables, listings, and figures for safety and efficacy data.
Collaborate with global cross-functional teams to ensure data quality through program creation and validation.
Bachelor's degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific field.
At least 3 years of statistical programming experience in a clinical development environment.
Working knowledge of CDISC SDTM standards; familiarity with CDISC ADaM and Define standards.
Fluency in English communication and ability to work in globally dispersed teams.
Experienced in clinical trial operations with strong programming skills in SAS and/or R, focused on clinical data manipulation and reporting.
Capable of adhering to challenging timelines and producing quality deliverables in a global team environment.
Familiar with data quality checks, regulatory submission processes, and implementing CDISC standards.