HOW MIGHT YOU DEFY IMAGINATION?
You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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 Manager
Live
What you will do
Let’s do this. Let’s 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 Amgen’s 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
Win
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:
Doctorate degree
OR
Master’s degree and 3 years of statistical programming in the pharmaceutical industry
OR
Bachelor’s degree and 5 years of statistical programming in the pharmaceutical industry
OR
Associate’s degree and 10 years of statistical programming in the pharmaceutical industry
OR
High school diploma / GED and 12 years of statistical programming in the pharmaceutical industry
Preferred Qualifications:
Master’s 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
Thrive
What you can expect of us
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
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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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.