Career Category
Research
Job Description
Amgen is expanding its global Biomedical Data Stewardship (BMDS) capabilities, with Amgen India (AIN) playing an increasingly critical role in integrated delivery and functional leadership. As Senior Manager, Biomedical Data Stewardship, you will help advance Amgen’s analysis and reporting standards by leading India-based execution while partnering closely with global BMDS and cross-functional teams.
You will manage and develop BMDS staff and managing resources, as well as oversee the development, governance, and consistent implementation of analysis and reporting data standards, including ADaM, in support of the Design & Innovation function within the Center for Design & Analysis. This position combines hands- on technical depth, managerial accountability, and cross-functional collaboration to ensure data standards are fit-for-purpose, inspection-ready, and aligned with Amgen’s global clinical development strategy.
Responsibilities:
- This role supports global Biomedical Data Stewardship objectives through India-based execution and cross-functional collaboration.
- Collaborate with global BMDS leadership and cross-functional partners to ensure alignment with enterprise standards strategy.
- Support development and maintenance of data element standards (DES) with a focus on analysis and reporting standards including Analysis Data Model (ADaM)
- Provide subject-matter leadership and input into the strategic adoption and implementation of Clinical Data Interchange Standards Consortium (CDISC) standards and regulatory guidance documents
- Stay abreast of latest developments and requirements in the field of analysis and reporting standards, CDISC, and regulatory guidance/practice
- Support process improvement initiatives related to the governance of standards
- Ensure changes to standards are implemented consistently and in a timely manner
- Manage and develop Biomedical Data Stewardship staff and managing resources
- Support d