Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs.
Program and QC tables, listings, and figures (TLFs) for interim and final clinical study reports, regulatory submissions, and client deliverables.
Interpret study protocols, SAPs, and data standards to translate clinical objectives into analysis-ready datasets and outputs.
Act as primary programming contact for assigned studies, collaborating closely with statisticians, data managers, and medical writers in a fully remote, fast-paced environment.
Conduct independent QC and peer review of programming deliverables, ensuring accuracy, compliance, and reproducibility of results.
Develop and maintain study-specific programming specifications, documentation, and macros to streamline programming efficiency.