HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Observational Research Programming ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will provide leadership to the Regulatory RWE Programming team in the development and execution of real-world evidence (RWE) observational studies and ensures adequate and timely delivery of results. The individual will report to the Senior Manager of the Regulatory RWE Programming team in CfOR, and is responsible for operational oversight of team projects in addition to planning, organizing, and managing resources to ensure high-quality and timely delivery of observational research programming deliverables. Leads and contributes to efforts to identify, develop, and implement departmental standards, applications, processes, and training. This position requires the management of a geographically distributed technical team, as well as a broad, comprehensive understanding of statistical programming languages and platforms, real-world data, claims and EMR databases, and current regulatory data standards.
CfOR leads Amgens strategic effort to effectively demonstrate RWE to conduct observational research studies and help increase the efficiency of drug development and drug commercialization. CfOR at Amgen partners with teams to generate RWE supporting a wide variety of business needs for multiple collaborators across the product lifecycle. Evidence generation activities include but are not limited to studies regarding the frequency and distribution of disease, the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, treatment cost, and utilization patterns, and the safety and efficiency of therapeutic interventions.
This manager will be responsible for operational oversight of Regulatory RWE Programming team projects within the Data and Analytics Center (DAC). This role is located on the Amgen corporate campus in Thousand Oaks, CA, with remote opportunities also considered. Key activities include:
- Oversight of regulatory filing analyses using Real World Evidence (RWE) to ensure compliance with both internal procedures and external regulations
- Development and implementation of data standards and study processes for use in regulatory filings containing RWE
- Execute and lead the programming for observational research studies across multiple types of data including medical claims, electronic health records, and survey data
- Work cross-functionally to establish and maintain priorities on projects and allocate staff and FSP external workers to projects in alignment with business and product priorities
- Communicate and interpret technical, and scientific information to a variety of audiences
- Effective people management, through staff development, engagement, and performance management
- Implement innovative ways for working with Big Data in healthcare, such as using common data models, data visualization, and efficiency initiatives in large databases
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Observational Research Programming Manager we seek is a leader with these qualifications.Basic Qualifications:
Masters degree and 3 years of statistical programming in the pharmaceutical industry
Bachelors degree and 5 years of statistical programming in the pharmaceutical industry
Associates degree and 10 years of statistical programming in the pharmaceutical industry
High school diploma / GED and 12 years of statistical programming in the pharmaceutical industryPreferred Qualifications:
ThriveWhat you can expect of us
- Masters degree in Epidemiology, Biostatistics, Computer Science, or other subject with high statistical content
- 5+ years of relevant statistical programming experience
- Previous experience with regulatory filings, especially where RWE was included
- Comprehensive understanding of Real-World Data (RWD)
- Experience applying CDISC standards to RWD
- Experience handling programming teams
- Experience working effectively in a globally dispersed team environment with cross-cultural partners
- Prior staff development leadership and project management experience
- In-depth knowledge of RWD and large claims dataset programming experience
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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 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.