Associate Director, Biomedical Data Stewardship (Standards Lead)
Amgen (company site, opens in a new tab)10+ yrsHyderabadOn-siteDirect career pageEst. 35–60 LPA
Posted 15h ago
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Job description
Structured overview of role & requirements
About This Role
- Lead and manage the India-based Biomedical Data Stewardship (BMDS) standards team, including staff development, resource allocation, and prioritization.
- Translate global BMDS standards strategy into an operational India delivery plan covering protocol, data collection, submission data, analysis, reporting, controlled terminology, and metadata.
- Serve as senior liaison across Clinical Data Management, Global Statistical Programming, Biostatistics, and Regulatory Writing; lead governance forums, oversee standards implementation, and report progress and risks to global leadership.
Minimum Requirements
- Bachelor's degree or higher in computer science, statistics, mathematics, life sciences, or related discipline.
- Over 10 years of experience in pharmaceutical or biotechnology industry.
- At least 5 years leading implementation of clinical data standards in a regulated environment.
- Experience managing direct reports and leading cross-functional clinical data standards work.
Ideal Candidate Profile
- Broad expertise in clinical data standards including protocol design, SDTM, ADaM, controlled terminology, metadata, and submission data lineage within drug development.
- Proven leadership in managing multidisciplinary teams and influencing multiple global functions to align priorities and standards.
- Experience with governance, policy development, audits/inspection readiness, process improvement, and standards lifecycle management in a regulated clinical development setting.