Biostatistical Programming Sr Mgr (US-Remote)
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Biostatistical Programming Sr MgrLive
What you will do
Lets do this. Lets change the world. In this vital role, theBiostatistical Programming Sr Mgrwill work in Amgen's Biosimilar organization supporting multiple products.
- Represent the product programming function and participate in multidisciplinary project team meetings.
- Coordinate and oversee the development of dataset specifications and implementation of TLGs according to the statistical analysis plans, work practices, and project timelines in close partnership with CROs in a full-service CRO model, including the review and analysis dataset specifications approval.
- Review or contribute to data management plans, database development, and edit checks plan.
- Contribute to and review the statistical analysis plans; and results presented in IBs, protocols, clinical study reports, integrated summaries of safety/efficacy, publications, and other documents, as required; provide support and input in protocol development, case report form design, and data collection.
- Operational effectiveness, Recommendations for Program Level Consistency and Submission Readiness including data standards.
- Work with CRO and Amgen team to put together the submission data packages.
- Lead and/or contribute to the technical solutions to implement CRO programs on Amgen system and perform ad-hoc analysis to support submission and publications need.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.Basic Qualifications
- Doctorate degree and 2 years of relevant experience OR
- Masters degree and 6 years of relevant experience OR
- Bachelors degree and 8 years of relevant experience OR
- Associates degree and 10 years of relevant experience OR
- High school diploma / GED and 12 years of relevant experience
- MSc or higher degree in quantitative or scientific subjects
- At least 6 years of relevant statistical programming experience in a clinical development environment
- In depth knowledge of SAS Graph, SAS -BASE, SAS STAT, SAS Macro and SQL
- Working knowledge of latest CDISC SDTM, ADaM, data quality and compliance checks (e.g. Pinnacle 21), and Define-XML standards
- Ability to lead and manage programmers in the successful and timely completion of all programming activities for a project
- Regulatory submissions experience
- Experience of working within a global team and CRO partners to ensure operational excellence and efficiencies.
What you can expect of us
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.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.com
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.
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.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.