Senior Manager - Statistical Programming, Central Services
Build our future together:Regeneron is founded on the belief that the right idea, combined with the right team, can lead to meaningful progress. Our growing global organization is dedicated to inventing, developing, and commercializing medicines that change lives for people with serious diseases. As we continue to expand our global footprint, our Global Capability Centers play a critical role in enabling scalable, high-quality operations and delivering impactful business services.We are seeking a Senior Manager, Statistical Programming to join our Global Development function, supporting our Global Capability Center in Hyderabad in an on-site role. In this role, you will lead statistical programming activities across clinical programs, ensuring high-quality, compliant data outputs for regulatory submissions and integrated analyses, while collaborating with biostatisticians, data management, and cross-functional global teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.When & where:This position is office-based and will be on site at Regeneron’s Hyderabad office.Discover your role:Serve as the technical lead for statistical programming across assigned clinical programs and regions.Lead the development of integrated datasets and analysis outputs for clinical studies and regulatory submissions.Coordinate the preparation and review of electronic submission packages (eCTD) for global regulatory bodies.You bring strong analytical thinking and attention to detail, ensuring quality in every deliverable.Drive process improvements and innovation to enhance efficiency and compliance across programming functions.Partner with biostatisticians, data management, and cross-functional teams to deliver clinical reporting needs.Mentor team members, building capability and fostering continuous learning across the function.You thrive working across a global, matrixed organisation, building alignment with diverse team members.This role requires:8+ years of experience in statistical programming within pharmaceutical, biotech, or clinical research, including leadership experience.Proficiency in SAS programming with deep understanding of CDISC standards (SDTM, ADaM, Define-XML).Proven experience supporting regulatory submissions to global bodies (FDA, EMA, PMDA).Strong experience with clinical trial data and regulatory reporting processes.Bachelor's degree in a relevant field.Fluency in English with the ability to collaborate effectively across global teams.Preferred:Master's degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or related field.Prior experience in global or Global Capability Center (GCC) environments.Exposure to R or Python.Experience with validation tools such as Pinnacle 21 (P21).Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with...