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Job Description

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.

Operational Design Analytics Senior Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will work with study teams during trial design and study start-up to use data-driven approaches to build rigor into operational planning and improve the probability of executing clinical trials within time and budget. You will be instrumental in using the latest techniques to access relevant data assets at Amgen, perform the necessary modeling, and present the data to study teams in an informative way. You will also proactively see opportunities for data utilization to optimize trial performance. This specialist role will work in partnership with the Operational Design Lead to support study teams with their operational protocol design and planning.

The Operational Design Analytics Senior Manager joins the Operational Design team within the Global Clinical Program Management (GCPM) function which is rapidly expanding to deliver our extensive pipeline of products moving into clinical development. We are excited to unite with the most passionate and brilliant scientific minds who want to join our team – working toward our mission of advancing high potential programs for patients around the world.

Key Responsibilities include:

• Identification of opportunities for the use of data to inform study planning, including global trial performance data, real world data platforms, and other data assets at Amgen.
• Curate relevant data to formulate a recommendation on which countries and sites to include in feasibility based on a study’s specific needs and present outputs to study team.
• Use of internal and external data assets to predict initial parameters of feasibility (population prevalence and historical performance metrics of enrollment rate, screen failure rate, dropout rates and completion rates). Partner closely with the feasibility group to build a shared understanding of the implications that historical performance metrics can have on enrollment planning for the global study.
• Use predictive models to understand enrollment duration and probability of success for various operational scenarios.
• Present analysis outputs and contextualize results for study teams to inform on speed/cost trade-off scenarios.
• Advise on protocol requirement challenges by quantifying the impact of certain eligibility criteria on recruitment and retention rates.
• Advise study team on risks to study operational plan and potential mitigation strategies based on predictive scenarios.
• Drive the delivery/development of analytics and visualization solutions that support clinical trial design and the identification of operational risk.
• Monitor external data use landscape in study planning and actively identify potential new data sources/tools/opportunities for considerations. Drive/assist business case preparation.
• Advocate for and disseminate the value of the use of these data in clinical trial planning.

Win

What we expect of you

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

Basic Qualifications

Doctorate degree and 2 years of relevant experience OR

Master’s degree and 6 years of relevant experience OR

Bachelor’s degree and 8 years of relevant experience

Preferred Qualifications

• Experience in using data and analytics to inform clinical trial planning and design
• Expertise in clinical data sources and understanding of how / when to apply them.
• High-level fluency in real world data, clinical trial data, and available landscaping data, with appreciation of how these data insights will affect the operationalization of a study.
• Organize and synthesize large amounts of complex data sets, extract and clearly communicate relevant outputs for clinical development planning and operational execution
• A strong track record in delivering innovative analytic software solutions
• Excellent facilitation, influencing, and negotiation skills
• Ability to work effectively in a fast-paced dynamic environment and execute across multiple urgent deliverables
• Ability to build effective relationships with study team members
• Proactive problem solving through innovative and pragmatic solutions

Thrive

What you can expect of us

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.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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