Statistical Programmer
Core
Prepare regulatory filing documentation, create and validate ADaM datasets, and develop SAS programs for clinical trial data analysis in accordance with CDISC standards.
Role type
Statistical Programmer (Clinical Data Management)
Builds
Regulatory submission datasets (ADaM), analysis-ready datasets, and dynamic/static visualizations for clinical pharmacologists and pharmacometricians.
Domain
Pharmaceutical R&D / Clinical Statistics
Required skills
SAS programming, NONMEM concepts, CDISC standards (ADaM), data validation, exploratory data analysis, data visualization, regulatory documentation writing, data integration from clinical/external/real-world sources
Technologies
SAS
Responsibilities
Prepare reviewer guides and data definition documents; combine varied data sources into analysis-ready datasets; conduct exploratory data analysis and create visualizations; develop and validate SAS programs for ADaM datasets, tables, listings, and figures; create specifications for ADaM dataset structures.
Seniority
Entry to Mid-level, hands-on IC