Manager Statistical programming (Hyderabad)

Manager Statistical programming (Hyderabad)

13 Aug
|
Regeneron
|
Hyderabad

13 Aug

Regeneron

Hyderabad

Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, Statistical Programming, Central Services to join our Statistical Programming team, supporting our Central Services function in a hybrid work model. In this role, you will lead statistical programming activities across integrated data and reporting, regulatory submissions, exploratory analyses, and clinical trial disclosure while collaborating with Statistical Programming, Biostatistics, Clinical Transparency and Trial Disclosure, and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:
Location: Hyderabad, India (Hybrid)

Discover your role:
Lead programming support for integrated datasets, pooled analyses, and reporting deliverables across assigned projects.
Create and maintain programming documentation, including integrated dataset specifications such as pooled ADaM datasets,



following established standards and processes.
Support the creation and review of electronic data packages for regulatory submissions to ensure compliance with regulatory, industry, and internal standards.
Coordinate with Clinical Transparency and Trial Disclosure, Biostatistics, Statistical Programming, and cross-functional teams to deliver disclosure-ready datasets and outputs.
Provide technical expertise in developing tools, standard processes, and programming solutions that improve efficiency and compliance.
Troubleshoot and resolve complex programming and submission-related issues while supporting inspection readiness activities and regulatory inquiries.
Collaborate effectively across teams to achieve submission and reporting objectives in a highly regulated setting.
Guide and support team members in developing their technical skills and knowledge of submission programming.

This role

📌 Manager Statistical programming (Hyderabad)
🏢 Regeneron
📍 Hyderabad

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