Director, Statistical Programming (India)

Director, Statistical Programming (India)

15 Aug
|
Alvotech
|
India

15 Aug

Alvotech

India

Job Title: Director, Statistical and Data Management Programming

About the Department/Company

Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines.

Within Research and Development (R&D;) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities.

iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position:

Overview of Job Role

The Director of Statistical and Data Management Programming will be responsible for establishing, leading and advancing statistical programming and Data Management (DM) programming activities for biosimilar studies, ensuring high-quality and timely deliverables.



They will provide strategic leadership and support the vision of both Statistical and DM programming functions through the establishment of robust programming capabilities, processes, standards, and quality frameworks. In addition, this role requires a hands-on approach, particularly during the build-out and maturation of the function, with direct involvement in programming activities, deliverable development, process implementation, and technical oversight.

Scope and responsibility
- Develop and guide the strategy for programming activities, ensuring adherence to standards and processes.
- Serve as functional expert and senior advisor for data standards, programming methodologies, and submission strategies.
- Contribute to developing and updating company-wide Standard Operating Procedures (SOPs) for DM and statistical programming.
- Establish and maintain programming standards, validation procedures, and reusable code libraries.
- Drive e

📌 Director, Statistical Programming (India)
🏢 Alvotech
📍 India

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