Manager - Statistical Programming

Regeneron; Hyderabad; Hybrid; INR 2,300,000 - 3,800,000; Full time

Job summary

Regeneron seeks a Manager, Statistical Programming, Central Services in Hyderabad, India. You will lead programming across integrated datasets and submissions, ensuring compliance and high-quality outputs for regulatory packages.

With 7+ years in clinical data programming, you will mentor the team, develop standards, and collaborate across Biostatistics, Clinical Transparency, and cross-functional partners to support disclosures and regulatory requirements.

Qualifications

• MS in Statistics, Biostatistics, Engineering, or related field.
• 7+ years of programming experience in biotech/pharma.
• Experience in regulatory submissions to FDA/EMA/PMDA and CDISC standards.

Responsibilities

• Lead programming for integrated datasets, pooled analyses, and reporting across projects.
• Create and maintain programming docs, including pooled ADaM datasets.
• Support electronic data packages for regulatory submissions and ensure regulatory compliance.
• Coordinate with Clinical Transparency, Biostatistics, and cross-functional teams to deliver disclosure-ready datasets.
• Develop tools and standard processes to improve efficiency and compliance.
• Troubleshoot complex programming and submission issues; support inspection readiness.
• Collaborate across teams to achieve submission and reporting objectives.
• Guide and mentor team members in submission programming.

Skills

SAS Programming

CDISC SDTM

ADaM

Define-XML

Pinnacle 21

Regulatory Submissions

GxP/Regulatory Compliance

Project Management

Cross-Functional Collaboration

Python/R

Education

MS in Statistics/Biostatistics or related field

Tools

SAS Base

SAS Macro

SAS Graph

Python

R

Job description

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?

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 a