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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

Responsibilities:

  • 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:

  • Basic 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)

  • Preferred Qualifications

  • 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

Join Us

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.

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, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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