Manager - Statistical Programming

Regeneron India Private Limited; Hyderabad; On-site; INR 2,500,000 - 4,500,000; Full time

Benefits offered by this job

Health benefits

401(k) match

Equity awards

Job summary

Regeneron India Private Limited in Hyderabad seeks a Manager, Statistical Programming to lead programming across integrated data, regulatory submissions, and disclosure outputs within a hybrid work model. You will coordinate with cross-functional teams, develop reusable tooling, and ensure compliance with CDISC standards and global regulatory requirements.

This role demands strong SAS expertise, project leadership, and a track record of delivering high-quality submission-ready datasets in a

Qualifications

• MS/BS in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
• 7+ years of programming experience in biotech/pharma setting.
• Experience with regulatory submissions and CDISC standards.

Responsibilities

• Lead programming support for integrated datasets, pooled analyses, and reporting deliverables.
• Create and maintain programming documentation and integrated dataset specifications (ADaM).
• Support the creation/review of electronic data packages for regulatory submissions.
• Coordinate with cross-functional teams to deliver disclosure-ready datasets and outputs.
• Develop tools and standards to improve efficiency and compliance.
• Provide guidance to team members and support inspection readiness.

Skills

SAS programming

CDISC SDTM/ADaM

Pinnacle 21

Regulatory submissions

Project leadership

SAS Macro/Graph

R/Python (plus)

Communication skills

Education

MS in Statistics/CS/Math

Tools

Pinnacle 21

eCTD software

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.

Job Requirements:

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.

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
• family support benefits

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.

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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.