Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Biomedical Data Stewardship Senior Manager

What you will do

Let’s do this. Let’s change the world. Amgen is seeking a dynamic and experienced Biomedical Data Stewardship Manager to drive the design, implementation, and governance of standardized data collection practices across our clinical programs. In this vital role, you will build and manage case report form (CRF) libraries, develop implementation standards, and partner closely with cross-functional teams to ensure high-quality data collection that supports drug development success. You will also lead standards implementation for study teams through hypercare sessions, monitor and review use of standards, and facilitate governance processes.

Key Responsibilities

• Lead the designation and definition of standard, indication-level CRF libraries using global standards-based and study-specific content and document implementation rules and decisions for their use in coordination with assigned subject matter experts.
• Lead the 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 where applicable.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of clinical experience

Or

Master’s degree and 4 years of clinical experience

Or

Bachelor’s degree and 6 years of clinical experience

Or

Associate’s degree and 10 years of clinical experience

Or

High school diploma / GED and 12 years of clinical experience

Preferred Qualifications:

• 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.
• Extensive 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.

What you can expect of us

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