AddressHOW 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.
Operational Design Analytics Senior Manager
Live
What you will do
In this crucial role, you will collaborate with clinical study teams to design, start-up, and execute trials using data-driven approaches, enhancing operational planning and increasing the likelihood of completing clinical trials within the allocated 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 cross-functional Data Science and Engineering Teams to drive optimization and enhancements of predictive analytics platforms, which the ODA Team leverages to inform operational planning and placement decisions.
The Operational Design Analytics Senior Manager joins the Operational Design Team within the Clinical Program Operations function, which is rapidly expanding to deliver our extensive pipeline of products to patients. 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:
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.
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.
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 qualified professional we seek is motivated 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
Or
Associate’s degree and 10 years of relevant experience
Or
High school diploma / GED and 12 years of relevant experience
Preferred Qualifications
Strong understanding of statistical modeling and how best to synthesize those insights to clinical study teams
Translate statistical algorithms to customized R packages and act as a Senior Technical Liaison between the ODA Team, and Data Science and Engineering teams
Experience building, maintaining and enhancing Shiny applications to drive improved analytical translations back to the business
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 clinical trial performance 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, 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.
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.
