• Lead all statistical programming activities for 1 or 2 assigned clinical studies, ensuring high-quality deliverables across the full study lifecycle. • Develop programming specifications based on the Statistical Analysis Plan and oversee the creation, validation, and delivery of CDISC-compliant SDTM and ADaM datasets, TLFs, Define.xml, and reviewer’s guides. • Provide hands-on SAS programming support for key analyses, data exploration, and internal or regulatory deliverables as needed. • Manage study programming timelines, coordinate dependencies, and ensure alignment with cross-functional study plans and milestones. • Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Safety teams to review requirements, refine specifications, and resolve data or programming issues. • Review Data Management Plans, case report forms, data transfer specifications, and validation plans to ensure downstream programming readiness. • Oversee CRO statistical programming activities, review outputs for accuracy and compliance, and ensure timely, high-quality delivery of datasets and analysis results. • Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components using industry tools (e.g., Pinnacle 21) and resolve compliance issues. • Develop and maintain SAS macros, utilities, and programming tools that improve efficiency, consistency, and scalability across study deliverables. • Ensure adherence to CDISC standards, regulatory expectations, departmental SOPs, and best practices for statistical programming and data traceability. • Mentor and provide technical oversight to junior programmers or contractors supporting assigned studies. • Contribute to departmental initiatives, process improvements, and cross-functional projects beyond assigned study responsibilities.