•San Diego, California, USA
Responsibilities: Manage programming activities on project or study level, including managing CROs to ensure deliverables are accurate and compliant. Act as a Programming SME for assigned studies, including authoring/reviewing programming specifications, such as SDTM/ADaM specifications, TFLs creation and QC for reporting events, ESUB packages, and documenting production and validation programs. Apply programming skills to support statistical analysis, clinical reporting, regulatory submission 