Principal Programmer/Associate Manager - Statistical Programming,Central Services

Regeneron India Private Limited; Hyderabad; Hybrid; INR 1,500,000 - 2,200,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Job summary

Regeneron is seeking an Associate Manager Statistical Programming Central Services in Hyderabad. The role supports integrated analyses, regulatory submissions, and disclosure activities in a hybrid work model.

You will deliver high‑quality programming solutions and collaborate with cross‑functional teams to ensure compliance and efficiency. The position requires strong SAS, CDISC, and P21 expertise, with 5+ years of programming experience in biotech/pharma and a track record in regulatory

Qualifications

• Requires MS/BS with experience in programming for clinical trial data and regulatory submissions.
• Proven experience supporting regulatory submissions and global standards (CDISC, FDA, EMA, PMDA).
• Strong communication, collaboration, and organizational skills with multi‑priority workload.

Responsibilities

• Create integrated datasets, pooled analysis data, reports, and programming documentation.
• Support electronic data packages for regulatory submissions and ensure compliance with global standards.
• Coordinate with biostatisticians and cross‑functional teams to deliver datasets for disclosures.

Skills

CDISC standards

Regulatory submissions experience

Project and people management

Education

MS in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline

BS with 6+ years experience

Tools

SAS (Base SAS, SAS/STAT, Macro, Graph)

Pinnacle 21 (P21)

eCTD submission formats

R

Python

Job description

Role Overview

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.

Location & Hybrid Model

When & where: Hyderabad, India (Hybrid).

Key Responsibilities

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.

Requirements

• 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.

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.

Benefits

• 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.

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.

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.