Functieomschrijving
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, Statistical Programming, Central Services to join our Statistical Programming team, supporting our Central Services function in a hybrid work model. In this role, you will lead statistical programming activities across integrated data and reporting, regulatory submissions, exploratory analyses, and clinical trial disclosure while collaborating with Statistical Programming, Biostatistics, Clinical Transparency and Trial Disclosure, and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
Location: Hyderabad, India (Hybrid)
Discover your role:
Lead programming support for integrated datasets, pooled analyses, and reporting deliverables across assigned projects.
Create and maintain programming documentation, including integrated dataset specifications such as pooled ADaM datasets, following established standards and processes.
Support the creation and review of electronic data packages for regulatory submissions to ensure compliance with regulatory, industry, and internal standards.
Coordinate with Clinical Transparency and Trial Disclosure, Biostatistics, Statistical Programming, and cross-functional teams to deliver disclosure-ready datasets and outputs.
Provide technical expertise in developing tools, standard processes, and programming solutions that improve efficiency and compliance.
Troubleshoot and resolve complex programming and submission-related issues while supporting inspection readiness activities and regulatory inquiries.
Collaborate effectively across teams to achieve submission and reporting objectives in a highly regulated environment.
Guide and support team members in developing their technical skills and knowledge of submission programming.
This role requires:
MS (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or a related field.
7+ years of programming experience, preferably processing clinical trial data within the biotechnology, pharmaceutical, or health-related industry.
Proven experience in regulatory submissions and compliance with global standards, including FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), and Clinical Data Interchange Standards Consortium (CDISC) requirements.
Proficient SAS programming skills in a clinical data environment with expertise in at least one, preferably multiple, therapeutic areas.
Strong understanding of CDISC standards, including Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Define-XML.
Proficiency with Pinnacle 21 (P21), including experience reviewing and troubleshooting P21 reports and issues.
Good knowledge of electronic Common Technical Document (eCTD) regulatory submission formats.
Experience with project and people management, including leading teams and managing deliverables.
Strong problem-solving skills with the ability to handle complex technical and programming challenges.
Proficiency with SAS Base, Stat, Macro, and Graph.
Excellent communication and interpersonal skills, with the ability to collaborate across functional areas.
Strong attention to detail and the ability to manage multiple priorities in a fast-paced environment.
SAS certification is a plus.
Knowledge of open-source programming languages such as R and/or Python is a plus.
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, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.