Principal Scientist - Data Analytics and Pharmacometric Modeling (US-Remote)

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Principal Scientist - Data Analytics and Pharmacometric Modeling

Live

What you will do

Lets do this. Lets change the world. In this vital role, you will be responsible for developing and implementing an integrated predictive analytics strategy to complement the pharmacometric modeling to make robust inferences to support clinical drug development across diverse therapeutic areas. You will partner closely with other CPMS scientists across therapeutic areas as well as external vendors/partners to develop and support innovative data science based pharmacometric analyses and implement Modeling and Simulation (M&S) strategy to efficiently accelerate drug development by enabling quantitative decision making.

Amgen is seeking a highly motivated and team-oriented Principal Scientist in the Clinical Pharmacology, Modeling and Simulation (CPMS) Department, focusing on use of data science and predictive analytics methodologies to support drug development via pharmacometric and quantitative systems pharmacology modeling.

The Principal Scientist will work closely with other functions within Amgen, collaborating with other functional areas within experimental sciences (such as clinical pharmacology, digital health, pharmacokinetics and drug metabolism, and clinical biostatistics). In addition, the senior scientist will assist in a wide range of activities such as working on complex datasets, recommending novel machine learning tools and statistical modeling of historical and preclinical data.

The typical role includes the development of machine learning tools, data visualizations, quantitative pharmacometric models, disease progression models, mechanistic and empirical PK/PD models, clinical trial simulations, literature meta-analysis using quantitative approaches and other innovative techniques. The candidate is encouraged to be able to integrate modeling and simulation results into cross functional interactions, regulatory filings and their application to dose selection, study design, risk/benefit, and advising drug development decisions in close collaboration with other R&D partners.

• Design modeling and simulation and analytics components of clinical drug development plans and provides expertise to project teams including plan, design, execution and oversight of M&S plans for multiple programs in Amgen portfolio.
• Responsible for planning and implementation of analyses to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs.
• Contribute to the analysis of in-vitro and pre-clinical PK/PD data for selection of first in humans (FIH) dose levels and contributes to IND submissions and documentation of appropriate reports.
• Contribute to recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and Development teams and in regulatory documentation.
• Influence external environment through methods such as publication and presentations.
• Responsible for collaborating with partners (e.g. clinical pharmacologists, clinical assay group, statistics) to ensure appropriate support for programs and studies.
• Provide thought leadership, guidance and advice in own field, and develop innovative and creative output based on interpretation and analysis

Win

What we expect of you

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

Basic Qualifications

• Doctorate degree and 3 years relevant experience OR
• Masters degree and 6 years of relevant experience OR
• Bachelors degree and 8 years of relevant experience

Preferred Qualifications

• PhD in Statistical and Data sciences, Computer Science, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees (e.g. MD, PharmD), and 3+ years experience in the life sciences, Biotechnology/Pharmaceutical Industry, consulting or post-doctoral training
• Demonstrated experience with scripting and implementing data analytics algorithms and models. Hands on experience using a modeling and simulation software (e.g. Python, Matlab, R, NONMEM, SAS, S-Plus, etc) is a plus
• Knowledge/Experience in the usage of machine learning/AI tools in life science area(s) and handling life science datasets is preferred
• Experience in PK/PD modeling and population-based analyses/simulations with established track-record of model-based drug development in multiple therapeutic areas will be an advantage
• Excellent interpersonal, technical, and communication skills to lead cross-functional teams
• Previous record of scientific contributions through peer-reviewed articles and external presentations

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.

• 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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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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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.