Use significant knowledge of SAS software and applications, clinical drug development, statistical concepts, industry standards, and demonstrated ability in providing deliverables to meet downstream requirements to design, develop and implement technical solutions for integrating, analyzing and reporting clinical data. Provide programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices. Develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications and standards. Develop unambiguous and robust programming specifications (e.g. ADaM specifications). Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; assess document robustness and impact on programming activities. Produce analysis datasets and TFLs (Tables, Figures and Listings). Process upstream data (e.g. multiple data forms, workflows, eDC, SDTM). Develop collaborative relationships and work within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams. Support and lead improvement initiatives; plan, implement, and identify issues/risks and provide remediation strategies to facilitate decision making. Lead and support the change management process (e.g. communication, training, stakeholder engagement) and the electronic submission preparation and review. Identify, lead, and support opportunities to enhance processes and technology using knowledge of clinical data structure (e.g. CDISC standards) and relational databases. Communicate proactively and effectively around issues and risks and contributes to its remediation using expertise in statistical programming and in developing computing strategies. May telecommute 100% of time from anywhere in the United States.Requirements: Bachelor’s degree (or foreign equivalent) in life sciences, statistics, biostatistics, computer science, mathematics or a related field plus 7 years of post-baccalaureate clinical/statistical programming experience within pharmaceutical clinical development reflecting demonstrable ability in the skill set described above.