Clinical Design Analytics Senior Manager

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. 

What you will do

Let’s do this! Let’s change the world. In this vital role you will partner with product/study teams and proactively find opportunities for data utilization to influence and drive decision making in program/study strategy and design.

The Clinical Design Analytics organization (CDAO), of the Center for Design and Analysis (CfDA), within the Global Clinical Development organization is rapidly growing our hiring initiatives and are excited to unite with the most passionate and brilliant clinical development talents who want to join our team –working toward our mission of advancing high potential programs for patients around the world.

The Clinical Design Analytics role works with product/study teams throughout the development life cycle to drive the use of data to inform the design of clinical programs and studies at Amgen. This role will have expertise in the various data sources and tools available at Amgen and provide data analyses for insight generation. Additionally, this role works in partnership with cross functional data experts to synthesize design and operational insights, and provide teams with analyses on design options as they pertain to evidence generation, clinical development planning, program/study design, and operational considerations.

Key Responsibilities include:

• Identification of opportunities for the use of data to advise program and study design, including: patient-level historical clinical trial data (HTD), real world data (RWD) assets, and other data assets at Amgen.
• Use of these tools and data sources to provide product teams with analyses and insights to advise clinical program and study strategy and design. For example, the interpretation of data to inform indication selection, study eligibility requirements, study endpoints etc.
• Coordination and delivery, where appropriate, of more detailed/complex analyses, in partnership with functional subject matter experts
• Internal/external thought leader and point of contact for historical trial data at Amgen. Participation in external data sharing initiatives to ensure procurement of data relevant to Amgen development teams, in accordance with our emerging pipeline.
• Ensuring a customer (product team)-focus of various data groups across Research and Development. Monitor and advise data owners and data science teams on the requirements of development teams: common questions; new tool generation; data gaps; etc. Proactively contribute the clinical development perspective on the strategic fit for potential data acquisitions.
• Monitor external data use landscape in development and actively identify and assess potential new data sources/tools/opportunities for considerations. Drive/assist business case preparation.
• Advocate for and disseminate the value and use of various data that supports decision making in the overall drug development life cycle.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is adept with these qualifications.

Basic Qualifications

• Doctorate degree and 2 years of research design experience Or
• Master’s degree and 6 years of research design experience Or
• Bachelor’s degree and 8 years of research design experience Or
• Associate’s degree and 10 years of research design experience Or
• High school diploma / GED and 12 years of research design experience

Preferred Qualifications

• Strong facilitation, influencing, and negotiation skills
• 6+ years of clinical research design experience in a clinical trials setting
• End-to-end product clinical development knowledge and experience
• Expertise in clinical data sources and understanding of how / when to apply them (fit for purpose approach); including Real World Data; clinical trial data;
• Ability to integrate and synthesize data as it relates to evidence generation and apply to facilitate data-driven decision making
• Understands how data and analytics can advise study design, development options, and knows where / when to apply them
• Contextualizes data and objectives for analytical partners
• Leadership capabilities to guide and motivate others and drive deliverable
• Excellent verbal and written communication skills
• Builds and manages relationship for collaboration

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.

careers.amgen.com

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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.