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Tier-1 employer and metro location increase applicant density, while niche biostatistics skills limit broad competition.
Biostatistical programming skills and CDISC experience are highly industry-specific to pharma/biotech.
Explicit 3+ years, mandatory SAS/CDISC/ADaM and regulatory experience create stringent screening filters.
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Perform hands-on statistical programming for clinical trial data analysis (phase 1 to 4) and regulatory submissions using SAS and/or R.
Create and validate SDTM, ADaM datasets, and tables/listings/figures for safety and efficacy data.
Maintain tracking and validation documentation; collaborate globally with cross-functional study teams to ensure data quality and compliance.
Bachelor's degree 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.
Strong skills in SAS programming, data manipulation, analysis, and reporting of clinical trials data.
Experienced in clinical trial operations with proven ability to deliver quality programming outputs under tight timelines.
Proficient in globally dispersed team environments, collaborating cross-culturally on clinical study teams.
Knowledgeable in data quality and compliance check tools, with awareness of emerging technologies such as R, Python, and automation platforms.