Job Information
Amgen Biomedical Data Stewardship Senior Manager in Washington D.C., District Of Columbia
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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
Let’s do this. Let’s 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
Win
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 ofclinical experienceORMaster’s degree and 4 years of clinical experienceORBachelor’s degree and 6 years of clinical experienceORAssociate’s degree and 10 years of clinical experienceORHigh school diploma / GED and 12 years of clinical experience
Preferred Qualifications
Bachelor’s or master’s 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.