Amgen ADaM Standards Lead (Open to Remote) in Los Angeles, California
Title: Biomedical Data Stewardship Sr. Manager
Department: Center for Design & Analysis (CfDA) – Design & Innovation – Biomedical Data Stewardship (BMDS)
Reports to: Director, BMDS
Develop and maintain processes for the design and implementation of data element standards (DES) with emphasis on ADaM standards
Provide strategic direction in the adoption and implementation of CDISC ADaM standards with appropriate level of documentation
Ensure that Amgen decisions with respect to ADaM implementation are ADaM-compliant and are in line with industry guidance
Manage standards content in a metadata repository (MDR)
Identify and champion opportunities to improve efficiency and compliance via improved technological solutions, including process automation
Liaise with cross-functional R&D groups to continually advance, and oversee standards, technical quality and consistent approaches in DES implementation
Collaborate cross-functionally and within Data Stewardship to improve compliance with the evolving standards, processes and training relating to DES
Track key metrics and provide reports of DES adherence
Provide DES expertise to stakeholders across R&D
Promote awareness of the role of the Data Stewardship organization, across R&D
Stay abreast of latest developments and requirements in the field of DES and regulatory guidance/practice
Contribute to resource and budget planning
Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents
May participate in external activities (e.g. Industry, academic) Key Skills / Knowledge:
In depth knowledge/experience of data collection, analysis, and reporting in drug development and clinical trials processes
Collaborating in 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 Qualifications:
Bachelor’s degree in statistics/ biostatistics, programming, life science, computer science, business administration or related discipline or equivalent combination of education and experience.
8 or more years knowledge/experience in clinical research and development in a statistics and/or programming environment
Demonstrated effective communication skills (written and oral)
Master’s degree or higher in statistics/ biostatistics, programming, life science, computer science, business administration or related discipline
7+ years cumulative work experience in data management, biostatistics or programming in Pharmaceutical / Biotechnology industry
5+ years’ experience in a global organization
Strong facilitation, influencing, and negotiation skills
Prior regulatory submission experience with SDTM/ADaM data and define.xml
Process improvement leadership
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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