Regeneron

Pharmaceutical

Sr.Manager-StatisticalProgramming

₹32–55L ~AI est. Hyderabad, India FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“Sr. Manager - Statistical Programming at Regeneron. Skills: Statistical programming, Regulatory submissions, CDISC standards. Act as technical lead. Oversee dataset development”

What You'll Achieve.

Deliver high-quality outputs; Timely and accurate reporting

Industry & Context.

Pharmaceutical
Problems you'll solve

Analytical skills; Problem-solving skills; Troubleshooting skills

What They're Looking For.

Must Have

8+ years statistical programming experience, Leadership experience, Proven regulatory submission experience, Experience with clinical trial data, Fluency in English

Nice to Have

Bachelor's degree or higher, Global or GCC environments experience, R or Python proficiency

What You'll Do.

Act as technical lead

Oversee dataset development

Ensure timely delivery

Collaborate with biostatisticians

Lead eCTD preparation

Support clinical trial transparency

Provide subject matter expertise

Drive process improvements

Support inspection readiness

Collaborate across global teams

How You'll Work.

Team & Collaboration

Cross-functional global teams; Global teams alignment

Full 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. **This position is office-based and will be on site at Regeneron’s Hyderabad office.** **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. * P

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