Senior Manager - Statistical Programming Central Services

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

Job summary

Regeneron in Hyderabad is seeking a Senior Statistical Programmer to act as the technical lead for statistical programming across clinical programs. You will develop integrated datasets and analysis outputs for studies and regulatory submissions, coordinating eCTD packages for global bodies.

You will bring 8+ years of experience, SAS expertise, CDISC knowledge, and lead cross-functional teams to deliver high-quality reports in a global, matrixed environment.

Qualifications

• 8+ years of experience in statistical programming within pharmaceutical, biotech, or clinical research.
• Proficiency in SAS programming with CDISC standards (SDTM, ADaM, Define-XML).
• Experience supporting regulatory submissions to global bodies (FDA, EMA, PMDA).
• Strong knowledge of clinical trial data and regulatory reporting processes.
• Bachelor's degree in a relevant field.
• Fluency in English for global collaboration.

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 electronic submission packages (eCTD) for global regulatory bodies.
• Ensure quality and accuracy of deliverables with strong attention to detail.
• Drive process improvements and innovation to enhance efficiency and compliance.
• Partner with biostatisticians, data management, and cross-functional teams to deliver clinical reporting needs.
• Mentor team members and build capability within the function.
• Collaborate effectively across a global, matrixed organisation.

Skills

Statistical programming

SAS

CDISC SDTM/ADaM

Regulatory submissions

Leadership

English communication

Education

Bachelor's degree in Statistics/CS/Life Sciences

Master's degree preferred

Tools

Pinnacle 21 (P21)

Job description

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.

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).

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 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.

If you have any questions, please speak with your recruiter.

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. Please speak with your recruiter and hiring manager for more information about onsite 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.

For jobs in Canada: this posting is for an existing position.