Data Standards & Metadata Governance Lead
Amgen (company site, opens in a new tab)12–17 yrsHyderabadOn-siteDirect career pageEst. 30–55 LPA
Posted on 8 Sept
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Job description
Structured overview of role & requirements
About This Role
- Lead India-based execution and governance of data standards supporting Precision Medicine and Clinical Data Hub needs within global Biomedical Data Stewardship.
- Manage and validate Metadata Repository (MDR) entries, quality control reports, and ensure alignment with Global or Product Standards across multiple functional areas.
- Collaborate closely with global BMDS leadership and cross-functional teams to improve clinical data accessibility, interoperability, and compliance with regulatory standards.
Minimum Requirements
- Bachelor’s degree (or equivalent) in computer science, statistics/biostatistics, programming, life science, or related discipline.
- 12-17 years professional experience in relevant fields such as statistics, programming, life sciences, or related areas.
- In-depth knowledge and experience with CDISC Standards including SDTM and ADaM, controlled terminology, and data standards governance.
- Experience working in regulated Clinical Development settings and adherence to regulatory and inspection readiness standards.
Ideal Candidate Profile
- Senior-level experience combining hands-on technical expertise and cross-functional collaboration in clinical data standards and governance.
- Demonstrated capability in managing metadata repositories, version control, quality control processes, and regulatory compliance in clinical trial data.
- Experience with end-to-end drug development lifecycle, process improvement leadership, and effective stakeholder communication across global teams.