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Clinical Design Analytics Senior Manager

at Amgen Inc.

Posted: 10/1/2019
Job Status: Full Time
Job Reference #: R-82900-1
Keywords:

Job Description

Career Category

Clinical

Job Description

Job Summary

In our mission to serve patients, speed is absolutely critical.  The Design and Innovation (D&I) group of the Center for Design and Analysis (CfDA) within the Global Clinical Development organization is rapidly expanding 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 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 partner with teams and proactively identify opportunities for data utilization to influence and drive decision making in program/study strategy and design.  The Clinical Design Analytics role will have expertise in the data sources and tools available at Amgen and will provide real-time, when applicable, analyses for insight generation.  Working with operationally-focused colleagues, this role will synthesize design insights and operational data sources to provide teams with analyses on design options as they pertain to operational considerations.

Key Responsibilities include:

  • Identification of opportunities for the use of data to inform program and study design, including: patient-level historical trial data (HTD), real world data assets, and other data assets at Amgen.
  • Use of these tools and data sources to provide product teams with real-time analysis and insights to inform 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, performed by 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 Global 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 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 development decision making.

Basic Qualifications

Doctorate degree and 2 years of clinical experience

OR

Master’s degree and 6 years of clinical experience

OR

Bachelor’s degree and 8 years of clinical experience

Preferred Qualifications

  • Strong facilitation, influencing, and negotiation skills
  • 6+ years of clinical research design experience in a clinical 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 inform 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 maintains relationship for collaboration

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.

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.

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Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing 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.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen



Posted 30+ Days Ago

Full time

R-82900