Manager Statistical programming

Regeneron; Hyderabad; Hybrid; INR 4,000,000 - 7,000,000; Full time

Job summary

Regeneron seeks a Manager of Statistical Programming to lead programming across integrated data and regulatory submissions. You will develop ADaM/SDTM datasets, ensure compliance with CDISC and eCTD standards, and collaborate with Biostatistics and Clinical Transparency teams.

7+ years of experience in clinical programming and strong SAS skills are required, with leadership ability to guide a skilled team in a fast-paced, regulated environment.

Qualifications

• MS (or BS with extensive experience) in a relevant field.
• 7+ years of programming experience in biotech/pharma settings.
• Experience with regulatory submissions and CDISC standards.
• Proficiency in SAS in a clinical data environment.

Responsibilities

• Lead programming activities across integrated data and reporting for submissions.
• Develop and review programming documentation and datasets (ADaM/SDTM).
• Coordinate with cross-functional teams to deliver disclosure-ready outputs.
• Troubleshoot complex submission-related issues and support inspections.
• Mentor team members and guide technical skills development.

Skills

SAS programming

CDISC SDTM/ADaM

Pinnacle 21 (P21)

eCTD regulatory submissions

R/Python optional

Leadership / mentoring

FDA/EMA/PMDA regulatory knowledge

Communication skills

Education

MS in Statistics / CS / Math / Engineering / Life Science

7+ years clinical programming experience

Tools

SAS Base/Stat/Macro/Graph

Job description

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:

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.