REMS Data Programming

Senior Manager – REMS Data Programming Contract | U.S. (Remote/Hybrid options) A global pharmaceutical organisation is seeking a Senior Manager, REMS Data Programming to join its REMS Strategy & Operations function on a contract-to-hire basis. This role plays a key part in supporting FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programmes and broader patient and product risk management initiatives. The position sits within a collaborative analytics and reporting team and works across U.S. and global stakeholders. You will lead REMS-related programming activities, partner closely with cross-functional teams, and ensure the delivery of high-quality, inspection-ready REMS assessment data. The role also includes exposure to senior leadership through data reviews and presentations. Key Responsibilities • Support the development, submission, and implementation of FDA-mandated REMS programmes and risk management initiatives to ensure patient and product safety. • Lead data programming activities for REMS and Risk Management, including development and review of statistical programs. • Provide advanced technical expertise across SAS, R, and Python, ensuring code is efficient, well-documented, and compliant with regulatory standards. • Develop and validate analysis datasets, tables, listings, and figures (TFLs) in line with CDISC standards. • Collaborate with cross-functional teams on REMS portal development, implementation, and maintenance. • Design and deliver interactive dashboards to visualise REMS assessment data, data quality metrics, and KPIs using Power BI. • Partner with Business Analysts and Solution Architects to design technical solutions aligned with business and stakeholder requirements. • Ensure audit readiness and support regulatory inspections related to REMS activities. • Contribute to day-to-day departmental activities supporting multiple REMS programmes. Required Experience & Skills • 6–8+ years within the pharmaceutical or life sciences industry. • 3–5+ years hands-on experience in data programming within REMS or similarly regulated environments. • Strong expertise in SAS, R, and/or Python. • Solid understanding of business analysis principles and cross-functional delivery. • Experience working with CDISC standards (certification desirable). • Excellent communication skills, with the ability to translate complex technical concepts for non-technical audiences. • Comfortable working in a fast-paced environment and managing multiple priorities. Education • Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related discipline required. • Master’s degree preferred.