Clinical Data Management & Biostatistics

Design and build clinical trial databases — electronic CRF design, edit check programming, data validation rules, medical coding (MedDRA, WHO Drug), and database lock procedures. Manage data cleaning cycles, query resolution, and CDISC standards compliance (CDASH, SDTM, ADaM).

Design statistical analysis plans, perform primary and sensitivity analyses for clinical trials, and produce Tables, Listings, and Figures (TLFs) for regulatory submissions. Program analysis datasets in SAS or R per CDISC ADaM standards.