Back
Login to See Your Match Score
Create a free account or log in to unlock your CV match score across:
Senior niche clinical data standards role at Amgen Hyderabad balances brand and metro pull, yielding moderate competition.
Specialized CDISC, SDTM/ADaM, and metadata governance make pharmaceutical background essential and less transferable.
Explicit 12–17 years and mandatory CDISC/regulatory standards create highly strict shortlisting filters.
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.
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.
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.