Amgen Inc. is hiring a Biomedical Data Stewardship Manager

At Amgen, our mission to serve patients drives everything we do. We are looking for a Biomedical Data Stewardship Manager to join our team. In this role, you will drive the design, implementation, and governance of standardized data collection practices across our clinical programs. You will build and manage case report form (CRF) libraries, develop implementation standards, and partner with cross-functional teams to ensure high-quality data collection that supports drug development success.

What You'll Do

• Design and define standard, indication-level CRF libraries using global standards-based and study-specific content and document implementation rules and decisions for their use.
• Design and review clinical data quality edit checks aligned with CRF content.
• Provide expert consultation and hypercare support to study teams in applying CRF library content and related tools.
• Monitor adoption and consistency of CRF standards, conducting audits and reviews to ensure alignment with evolving study and regulatory needs.
• Manage governance processes for evaluating and implementing updates or exceptions to CRF standards, including triage and adjudication of change requests.
• Coordinate with global standards governance bodies to ensure harmonized updates and compliant implementation across programs.
• Curate and manage standards content within a metadata repository (MDR), ensuring traceability, reusability, and consistency.
• Lead initiatives to expand data standards implementation across Amgen’s Global Development functions and external collaborations.

What We're Looking For

• Doctorate degree
• Or Master’s degree and 2 years of clinical experience
• Or Bachelor’s degree and 4 years of clinical experience
• Or Associate’s degree and 8 years of clinical experience
• Or High school diploma / GED and 10 years of clinical experience

Nice to Have

• Degree in a related field such as statistics, biostatistics, life sciences, programming, computer science, or business administration.
• 5+ years cumulative experience in data management, biostatistics, or clinical programming within the pharmaceutical or biotechnology industry.
• 3+ years of experience in a global, matrixed organization.
• Proven experience with CRF design, data standards governance, and clinical metadata repository (MDR) tools.
• Experience in data collection, analysis, and reporting within drug development and clinical trial processes as well as utilizing metadata repository systems to curate and maintain standards-related assets.
• Strong skills in project planning, stakeholder engagement, process improvement leadership, documentation development, training, and compliance.
• Proven ability to collaborate effectively build relationships on global cross-functional teams.
• Effective written and verbal communication, facilitation, and negotiation skills with all levels within the organization.
• Demonstrated success in SOP development and regulatory-compliant documentation practices.
• Proficient in the use of software and data applications relevant to drug development.

Technical Stack

• Clinical metadata repository (MDR) tools
• Software and data applications relevant to drug development

Team & Environment

You will be part of a global, matrixed organization at Amgen.

Benefits & Compensation

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Work Mode

This role operates on a hybrid work model. It is open to candidates located in the U.S. (excluding Puerto Rico).

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.