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 programming input into, cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review, data quality check specifications
- Initiate cross-functional team meetings as necessary
- Perform significant hands-on statistical programming, particularly for those most challenging deliverables
- Manage individual programmer work assignments to ensure timely, high-quality deliverables
- Provide technical leadership and guidance for study programming team
- Coordinate and monitor data issue reporting and resolution
- Coordinate with other SLPs to providi