Senior Manager - Statistical Programming, Central Services

BioSpace; Hyderabad; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Regeneron is seeking a senior Statistical Programmer to act as a technical lead across clinical programs, driving data delivery and regulatory submissions. You will develop integrated datasets and analysis outputs for studies and submissions, coordinating eCTD packages for global regulators while ensuring quality and compliance.

The role requires 8+ years in statistical programming, expertise in SAS and CDISC standards, and collaboration across biostatistics and data management in a global,

Qualifications

• 8+ years in statistical programming with leadership experience.
• Bachelor's degree in a relevant field.
• Experience supporting regulatory submissions with global bodies.

Responsibilities

• Serve as the technical lead for statistical programming across assigned clinical programs and regions.
• Lead the development of integrated datasets and analysis outputs for clinical studies and regulatory submissions.
• Coordinate the preparation and review of eCTD packages for global regulatory bodies.
• You bring strong analytical thinking and attention to detail, ensuring quality in every deliverable.
• Drive process improvements and innovation for efficiency and compliance across programming functions.
• Partner with biostatisticians, data management, and cross-functional teams to deliver clinical reporting needs.
• Mentor team members, building capability and fostering continuous learning.
• You thrive working across a global, matrixed organisation, aligning with diverse teams.

Skills

Statistical programming

SAS

CDISC SDTM/ADaM/Define-XML

Regulatory submissions

English

Education

Bachelor's degree in a relevant field

Tools

Pinnacle 21 (P21)

R

Python

Job description

Build Our Future Together
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to meaningful progress. Our growing global organization is dedicated to inventing, developing, and commercializing medicines that change lives for people with serious diseases. As we continue to expand our global footprint, our Global Capability Centers play a critical role in enabling scalable, high-quality operations and delivering impactful business services.

Build Our Future Together
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to meaningful progress. Our growing global organization is dedicated to inventing, developing, and commercializing medicines that change lives for people with serious diseases. As we continue to expand our global footprint, our Global Capability Centers play a critical role in enabling scalable, high-quality operations and delivering impactful business services.

When & Where

This position is office-based and will be on site at Regenerons Hyderabad office.

Discover Your Role

• Serve as the technical lead for statistical programming across assigned clinical programs and regions.
• Lead the development of integrated datasets and analysis outputs for clinical studies and regulatory submissions.
• Coordinate the preparation and review of electronic submission packages (eCTD) for global regulatory bodies.
• You bring strong analytical thinking and attention to detail, ensuring quality in every deliverable.
• Drive process improvements and innovation to enhance efficiency and compliance across programming functions.
• Partner with biostatisticians, data management, and cross‑functional teams to deliver clinical reporting needs.
• Mentor team members, building capability and fostering continuous learning across the function.
• You thrive working across a global, matrixed organisation, building alignment with diverse team members.

This Role Requires

• 8+ years of experience in statistical programming within pharmaceutical, biotech, or clinical research, including leadership experience.
• Proficiency in SAS programming with deep understanding of CDISC standards (SDTM, ADaM, Define-XML).
• Proven experience supporting regulatory submissions to global bodies (FDA, EMA, PMDA).
• Strong experience with clinical trial data and regulatory reporting processes.
• Bachelor's degree in a relevant field.
• Fluency in English with the ability to collaborate effectively across global teams.

Preferred

• Master's degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
• Prior experience in global or Global Capability Center (GCC) environments.
• Exposure to R or Python.
• Experience with validation tools such as Pinnacle 21 (P21).

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, 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 onsite.

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.