Senior Manager, Biostatistical Programming

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.

Senior Manager, Biostatistical Programming

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 a Senior Manager of Biostatistical Programming (Programming Execution Lead), you will partner with the Global Programming Lead (GPL) and lead an offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to ensure successful execution of end-to-end programming activities for products within or across therapeutic areas. Together with the GPL, this Senior Manager will be accountable and responsible for Global Statistical Programming study results and drug approval submission activities for the assigned product areas.

Key Responsibilities :

• Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of Amgen products, being supported by the offshore programming team.
• Work with GPL to ensure successful implementation of programming strategies, such as functional standards and industry requirements for the assigned product globally.
• Plan and monitor progress of projects and address issues accordingly.
• Provide GSP product level input to developing and managing resource plans and budgets for GSP.
• Efficiently and effectively monitor and utilize assigned staff at product level according to priorities.
• Lead and / or participate in departmental process improvement initiatives and cross-functional working groups.
• Assist in study and system audits and inspections by internal and external bodies.
• Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally.
• Provide hands-on support to the assigned product areas as required.
• Provide coaching and mentoring to local programming staff.
• Provide input into career development plans for all staff on assigned projects

This position will be located at Amgen India (Hyderabad).

Win

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation.

Basic Qualifications :

Preferred Skills :

Thrive

What You Can Expect Of Us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.

Skills Required

statistical programming, Sas Stat, Software Development, Project Management, Sas, Sql