Biomedical Data Stewardship Senior Manager

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have.

At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide.

Become the professional you are meant to be in this meaningful role.

Live

What you will do

Lets do this. Lets change the world. In this vital role you will create and uphold data standards and develop metrics to support the Design & Innovation function within the Center for Design & Analysis.

• Design, define, and review clinical trial data collection standards for inclusion in the library of data standards
• Design, define, and review data quality edit check standards for inclusion in the library of data standards
• Develop and maintain processes for the design and implementation of data quality edit check and clinical trial data collection standards
• Consult with study teams on the implementation of data standards
• Manage data standards content in a metadata repository (MDR)
• Lead or participate in cross-functional working groups to align operational and data collection standards requirements for lab analytes, clinical outcome assessments (COAs), and other standards touchpoints
• Develop and provide training and additional support for the adoption of standards throughout Amgen
• Drive and facilitate the expansion of standards across Amgen Global Development and beyond

What we expect of you

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

Key Skills / Knowledge :

• Knowledge / experience of data collection, analysis, and reporting in drug development and clinical trials processes
• Collaborate on global cross-functional teams
• Experience in project management, documentation writing, training, and compliance
• Interest in process improvement methodologies
• Use of software and data applications within drug development
• Appreciation of computer system architecture and hardware
• Experience with utilizing metadata repository systems to curate and maintain standards-related assets

Basic Qualifications

Doctorate degree and 2 years of clinical experience

Masters degree and 4 years of clinical experience

Bachelors degree and 6 years ofclinical experience

Associates degree and 10 years ofclinical experience

High school diploma / GED and 12 years of clinical experience

Preferred Qualifications

• Bachelors or masters degree in statistics / biostatistics, programming, life science, computer science, business administration or related subject area
• 5+ years cumulative work experience in data management, biostatistics or programming in Pharmaceutical / Biotechnology industry
• 3+ years experience in a global organization
• Strong facilitation, influencing, and negotiation skills
• Builds and maintains partnerships
• Project planning and management
• Process improvement leadership
• Participation in the development of policies and SOPs
• Effective communication skills (written and oral)

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities including :

• 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, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.