• Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of study projects via internal and/or external staff oversight. • Considered a statistical programming expert within the department. • Authors CDISC ADaM (analysis data model) analysis data set specifications including the identification of potential data issues or areas of critical data examination. • Works with statistics on defining and documenting programming endpoint algorithms across a study, drug program and/or contributing to TA level algorithms. • Manage the end-to-end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (ESUB) components (input to reviewer’s guides, annotated CRF, define and XPTs), works with SMEs to ensure compliance to eSUB standards. • Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with DVAD and PON. • Serves as the Statistical Programming Lead to achieve milestones for a drug program; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs. • Verifies program consistency and usage of data, analysis and submission standards across the department in consultation with data standards, statistical submissions management and the data strategy plan. • Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.