Regulatory RWE Programming Senior Manager

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Job Description

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.

Live

What you will do

The Biostatistical Programming Senior Manager within the Center for Observational Research (CfOR) provides leadership and technical expertise 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 Director 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 Senior 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

Basic Qualifications:

• Doctorate degree and 2 years of statistical programming in the pharmaceutical industry experience OR
• Masters degree and 6 years of statistical programming in the pharmaceutical industry experience OR
• Bachelors degree and 8 years of statistical programming in the pharmaceutical industry experience OR

Preferred Qualifications:

• Masters degree in Epidemiology Biostatistics Computer Science or other subject with high statistical content
• 8 years of relevant statistical programming experience
• Previous experience with regulatory filings especially where RWE was included
• Experience applying CDISC standards to Real-World Data or mapping Real-World Data to other common data models
• Experience managing programming teams

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

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.

• 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.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.

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.

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