Biomedical Data Stewardship Sr Mgr - SDTM Standards Lead
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.
Biomedical Data Stewardship Sr Mgr - SDTM Standards LeadLive
What you will do
Lets do this. Lets change the world. In this vital role you will [top-line statement connecting primary position responsibility to employer brand].
- Provide strategic direction in the adoption and implementation of CDISC SDTM standards with appropriate level of documentation
- Lead SDTM standard content review with Governance Council
- 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 SDTM implementation
- Collaborate cross-functionally and within the standards group to improve compliance with the evolving standards, processes and training
- Manage standards content in a metadata repository (MDR)
- Promote awareness of the role of the standards organization, across R&D
- Stay abreast of the latest developments and requirements for SDTM and regulatory guidance/practice
- Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Biomedical Data Stewardship professional we seek is a dynamic contributor with these qualifications.Basic Qualifications
- In depth knowledge/experience of industry standards such as CDISC and SDTM, 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
- Knowledge of metadata repository systems to curate and maintain standards-related assets
- Bachelors degree in statistics/ biostatistics, programming, life science, computer science, business administration or related subject area or equivalent combination of education and experience.
- 8 or more years' knowledge/experience in clinical research and development in statistics and/or programming environment
- Demonstrated effective communication skills (written and oral)
- Masters degree or higher in statistics/ biostatistics, programming, life science, computer science, business administration or related subject area
- 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 data and define.xml
- Process improvement leadership
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual Opportunity Statement
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 a 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 an accommodation.
Join UsIf 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.