Manager, Biostatistical Programming
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.Manager, Biostatistical ProgrammingLive
What you will do
Lets do this! Lets change the world. This vital role will support the CfOR organization by setting goals with CfOR epidemiologists, laying out a strategy to deliver on those goals, and coordinating with a functional service provider-based team of contract statistical programmers to achieve the goals. .
Amgen is seeking an Observational Research Programming Manager to join the Center for Observational Research (CfOR) organization. This individual will report to a Director in CfORs Data & Analytic Center. In addition, the Manager is responsible for staying informed of evolving department needs and industry best practices, looking to identify innovative, impactful proposals to increase efficiency and support the organizations growth strategies.
- Own an FSP-based statistical programming team conducting building standards for conducting analyses supporting Amgen's Pipeline product filings
- Coordinate with functional leads to prioritize and run workflow
- Lead FSP-based statistical programming team to deliver on time and to specifications
- Identify potential efficiency improvements and propose solutions
- Collaborate with CfOR FSP liaison to ensure performance and quality standards from FSP-based statistical programming team
- Ensure the analysis and presentation of biomedical data is accurate and complete
- Adherence to Amgen policies, SOPs and other controlled documents
- Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
- Efficiently lead project team resources and timelines
- Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
- Write, and/or review and approve programming plans
- Write, and/or review and approve analysis dataset specifications
- Represent the programming function and participate in multidisciplinary team meetings and supply to the continuous improvement of programming, CfOR, and Research and Development (R&D)
- Write, test and validate department-, product- and protocol-level macros and utilities
- Participate in the development and review of CfOR Policies, SOPs and other controlled documents
- Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
- Interview potential programming candidates, and support and mentor junior programmers
- Actively participate in external professional organizations, conferences and/or meetings and provide input to and participate in intra-departmental and CfOR meetings
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is dedicated with these qualifications.
- Doctorate degree in Computer Science, Statistics, Mathematics, or Life Sciences Or
- Masters degree and 3 years of Computer Science, Statistics, Mathematics, or Life Sciences Or
- Bachelors degree and 5 years of Computer Science, Statistics, Mathematics, or Life Sciences
- Masters degree in Epidemiology, Biostatistics, Computer Science, or other subject with high statistical content
- Vendor relationship management or related experience with functional service providers
- Experience in a regulated environment
- Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model
- Pharmaceutical proven experience
- Minimum five years SAS statistical programming experience
- Database programming using SQL or experience with advanced statistical methods such as survival and regression
- Experience with real world healthcare data such as Flatiron, McKesson, MarketScan, Optum, Medicare and EMR databases
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
for a career that defies imagination
Objects in your future are closer than they appear. 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.