Principal Programmer Associate Manager - Statistical Programming Central Services

Regeneron Pharmaceuticals, Inc.; Hyderabad; Hybrid; INR 3.000.000 - 5.000.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. seeks an Associate Manager Statistical Programming Central Services in Hyderabad, India, offering a hybrid work model.

The role focuses on building integrated datasets, supporting regulatory submissions, and advancing programming processes in a cross‑functional team. You will work with biostatisticians and clinical transparency teams to ensure high‑quality datasets and outputs for submissions and disclosures, while navigating CDISC standards and regulatory

Qualifikationen

• 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.
• Project and people management experience.
• Proven experience supporting regulatory submissions and compliance with global standards (CDISC, FDA, EMA, PMDA).
• SAS skills in a clinical data environment (Base SAS, SAS/STAT, Macro, Graph).
• Knowledge of open‑source languages such as R and Python is desirable.

Aufgaben

• Create integrated datasets, pooled analysis datasets, reports, and programming documentation per standards.
• Support electronic data packages for regulatory submissions in line with global standards.
• Coordinate with cross‑functional teams to deliver datasets and outputs for disclosures.
• Develop tooling and processes to improve efficiency and compliance.
• Troubleshoot programming, validation, and submission issues; support inspection readiness.

Kenntnisse

SAS programming

CDISC SDTM/ADaM/Define-XML

Pinnacle 21 (P21)

eCTD submission knowledge

R and Python

SAS certification

Ausbildung

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

BS in Statistics/CS/Math/Engineering/Life Science or related

Tools

SAS software

Pinnacle 21

eCTD tooling

Jobbeschreibung

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 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.

When & Where

Hyderabad, India (Hybrid).

Discover Your Role

• 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.

This Role Requires

• 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.

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.

We are committed to building a workplace with an inclusive culture.

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.

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.