Principal Programmer/Associate Manager - Statistical Programming, Central Services

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About the role

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager Statistical Programming Central Services to join our Statistical Programming team, supporting integrated analysis, regulatory submissions, and clinical trial disclosure activities in a hybrid work model. In this role, you will deliver high-quality programming solutions, support global regulatory submissions, and advance programming processes while collaborating with project programmers, biostatisticians, clinical transparency teams, and cross-functional partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a significant difference to patients worldwide. When & where: Hyderabad, India (Hybrid). Discover your role: • Create integrated datasets, pooled analysis datasets, reports, and programming documentation in line with established standards and processes. • Support the preparation and review of electronic data packages for regulatory submissions while ensuring compliance with global regulatory and industry standards. • Coordinate with Clinical Transparency and Trial Disclosure teams, biostatisticians, and cross-functional partners to deliver datasets and outputs required for disclosure activities. • Provide technical expertise in developing tools, standard processes, and programming solutions that improve efficiency and compliance. • Troubleshoot programming, validation, and submission-related issues and support the implementation of procedures across assigned areas. • Support inspection readiness activities and respond to programming-related inquiries during regulatory inspections. • Collaborate effectively across project programming teams and broader functions to achieve reporting and submission objectives. • You bring a diligent, problem-solving attitude and thrive in a fast-paced environment with multiple priorities. This role requires: • MS (or BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or a related discipline. • 5+ years of programming experience with an MS degree or 6+ years with a BS degree, preferably processing clinical trial data within the biotechnology, pharmaceutical, or health-related industry. • Project and people management experience. • Proven experience supporting regulatory submissions and compliance with global standards, including CDISC, FDA, EMA, and PMDA requirements. • Proficient SAS programming skills in a clinical data environment, including Base SAS, SAS/STAT, Macro, and Graph. • Strong expertise in CDISC standards, including SDTM, ADaM, and Define-XML. • Proficiency with Pinnacle 21 (P21), including reviewing and troubleshooting validation reports and issues. • Familiarity with electronic Common Technical Document (eCTD) submission formats. • Knowledge of open-source programming languages such as R and Python is highly desirable. • SAS certification is a plus. • Excellent communication, interpersonal, collaboration, problem-solving, and organizational skills, with strong attention to detail and the ability to manage multiple priorities. 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 an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, members

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