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Associate Director, Biostatistical Programming
Amgen
IND
Full-time
Senior · 10+ years experience
Onsite
Discovered 3 weeks ago
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HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
What you will do
- Let’s do this. Let’s change the world.
- Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As an Associate Director of Biostatistical Programming (Programming Execution Lead), you will partner with Global Programming Leads (GPL) and lead a large offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to successfully execute end-to-end programming activities for all studies and global regulatory approval submissions for large, high priority products or indications across products. Together with GPL, this Associate Director will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned products or indications across products.
- The Associate Director of Biostatistical Programming will contribute at the department level by leading major GSP technical or operational efficiency initiatives and ensuring compliance with R&D standards, leading or serving as a member of GSP and cross functional consultancy groups such as Submission Consultancy Group and ADaM Consultancy Group.
- The Associate Director will drive the piloting and integration of new technologies, including artificial intelligence, statistical programming automation tools, and open-source platforms to improve quality and efficiency across the organization.
Key Responsibilities
- Accountable and responsible for ensuring successful execution and delivery of GSP milestone analysis deliverables and regulatory submission packages for a group of high priority and/or high complexity Amgen products being supported by the offshore programming team.
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