• Function as lead programmer to produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs. • Develop/review TFL shells, SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues. • Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate. • Partner with or oversee CROs or Programming vendors to perform the tasks described above. • Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements. • Manages project timelines and schedules of specific phases of projects and collaborates with internal personnel and outside customer representatives. • Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).