BiostatisticalProgrammingManager

## **Career Category** Clinical ## ## **Job Description** **Biostatistical Programming Manager** **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. **Biostatistical Programming Manager** **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 Biostatistical Programming Manager, you will serve as the Study Lead Programmer (SLP) for one or more studies and lead a team of statistical programmers to support all statistical programming activities within a study. You may also support regulatory submissions. **Key Responsibilities:** * Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer * Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables * Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions) assigned to the team * Participate in establishing the programming scope for a deliverable with the statisticians and the study team * Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project * Create and maintain programming related specifications (e.g., SDTM and ADaM) for the studies/projects * Represent GSP at the Clinical Study Team (CST) * Attend meetings for, and provide progra