Amgen

Operational Design Analytics Senior Manager

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Oct 01, 2019
Ref
R-83910
Required Education
High School or equivalent
Position Type
Full time
In our mission to serve patients, speed and predictability are absolutely critical. The Operational Design Analytics Senior Manager works 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. This role 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. This role will proactively identify 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.

Responsibilities:
  • 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
  • Collate 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 Amgen 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 create a shared understanding of the implications that historical performance metrics can have on enrollment planning for the global study
  • Leverage 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 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


Basic Qualifications :

Doctorate degree and 2 years of clinical research experience

OR

Master's degree and 6 years of clinical research experience

OR

Bachelor's degree and 8 years of clinical research experience

OR

Associate's degree and 10 years of clinical research experience

OR

High school diploma / GED and 12 years of clinical research experience

Preferred Qualifications:
  • Experience in leveraging 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 aappreciation 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 proven 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


We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.