Sr. Manager - Statistical Programming, Central Services

Regeneron Pharmaceuticals, Inc; Hyderabad; Hybrid; INR 3,000,000 - 6,000,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. in Hyderabad, India, is seeking a Senior Manager – Statistical Programming to lead programming activities across clinical programs.

You will oversee integrated datasets and analysis outputs for submissions, ensuring timely, regulatorily compliant deliverables and collaboration with cross-functional teams. The role requires 8+ years in statistical programming within pharma/biotech, with strong SAS skills, CDISC standards expertise, and experience with eCTD

Qualifications

• 8+ years of relevant experience in statistical programming within pharmaceutical, biotech, or clinical research settings, including leadership experience.
• Bachelor’s degree required; Master’s degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or related field preferred.
• Proven experience supporting regulatory submissions and global compliance standards (FDA, EMA, PMDA).
• Strong experience working with clinical trial data and regulatory reporting processes.
• Prior experience in global or GCC environments is preferred.
• Fluency in English and ability to collaborate effectively with global stakeholders.

Responsibilities

• Act as a technical lead and primary point of contact for statistical programming activities across assigned projects and regions.
• Lead and oversee the development of integrated datasets (e.g., pooled ADaM) and analysis outputs for clinical studies and submissions.
• Ensure timely, high-quality delivery of programming outputs, adhering to internal standards and regulatory requirements.
• Collaborate with biostatisticians, data management, and cross-functional stakeholders to support clinical reporting and analysis needs.
• Lead the preparation and review of electronic submission packages (eCTD) in compliance with global regulatory standards (FDA, EMA, PMDA).
• Support clinical trial transparency and disclosure activities, ensuring accurate and timely delivery of required datasets and outputs.
• Provide subject matter expertise in statistical programming, including development of tools, standards, and best practices.
• Drive process improvements and innovation initiatives to enhance efficiency, quality, and compliance across programming functions.
• Support inspection readiness activities and address regulatory queries related to programming deliverables.
• Mentor and guide team members, fostering capability building and promoting a culture of continuous learning.
• Collaborate across global teams to ensure alignment with enterprise standards and successful delivery of project milestones.

Skills

Leadership

Team mentoring

Communication

Stakeholder management

Analytical thinking

Problem-solving

Troubleshooting

Education

Bachelor's degree

Master's degree or higher

Tools

SAS

Pinnacle 21

R

Python

Job description

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.

As a Senior Manager – Statistical Programming, you will serve as a technical leader within Global Development, providing oversight and guidance for statistical programming activities across multiple clinical programs. You will play a key role in delivering high-quality, compliant data outputs for regulatory submissions, integrated analyses, and clinical trial transparency. This role will also focus on driving operational excellence, enabling innovation, and collaborating with cross-functional global teams to ensure timely and accurate reporting aligned with industry and regulatory standards.

When & where:

Hyderabad, India (Hybrid)

A Typical Day May Include the Following:

• Act as a technical lead and primary point of contact for statistical programming activities across assigned projects and regions.

• Lead and oversee the development of integrated datasets (e.g., pooled ADaM) and analysis outputs for clinical studies and submissions.

• Ensure timely, high-quality delivery of programming outputs, adhering to internal standards and regulatory requirements.

• Collaborate with biostatisticians, data management, and cross-functional stakeholders to support clinical reporting and analysis needs

• Lead the preparation and review of electronic submission packages (eCTD) in compliance with global regulatory standards (FDA, EMA, PMDA).

• Support clinical trial transparency and disclosure activities, ensuring accurate and timely delivery of required datasets and outputs.

• Provide subject matter expertise in statistical programming, including development of tools, standards, and best practices.

• Drive process improvements and innovation initiatives to enhance efficiency, quality, and compliance across programming functions.

• Support inspection readiness activities and address regulatory queries related to programming deliverables.

• Mentor and guide team members, fostering capability building and promoting a culture of continuous learning.

• Collaborate across global teams to ensure alignment with enterprise standards and successful delivery of project milestones.

This Role May Be for You If You Have:

• Strong experience in statistical programming within clinical trials, including integrated analyses and regulatory submissions

• Deep understanding of CDISC standards (SDTM, ADaM, Define-XML) and regulatory requirements

• Proficiency in SAS programming, with additional exposure to R or Python considered beneficial.

• Experience with tools such as Pinnacle 21 (P21) for validation and compliance checks.

• Demonstrated ability to lead teams, manage multiple projects, and deliver results in a fast-paced environment.

• Strong analytical, problem-solving, and troubleshooting skills.

• Excellent communication and stakeholder management capabilities.

• Ability to work effectively in a matrixed, global organization and collaborate cross-functionally.

• High attention to detail with a focus on quality and compliance.

To Be Considered for This Role:

• 8+ years of relevant experience in statistical programming within pharmaceutical, biotech, or clinical research settings, including leadership experience.

• Bachelor’s degree required; Master’s degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or related field preferred.

• Proven experience supporting regulatory submissions and global compliance standards (FDA, EMA, PMDA).

• Strong experience working with clinical trial data and regulatory reporting processes.

• Prior experience in global or GCC environments is preferred.

• Fluency in English and ability to collaborate effectively with global stakeholders.

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., 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.

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.