Principal IS Informatics Analyst

Amgen is seeking Principal IS Informatics Analyst, to join the Development IS team at its main headquarters in Thousand Oaks, CA!! The Principal IS Informatics Analyst role will be dedicated to supporting the Translational Medicine's mission to work across Research and Development to improve the speed, predictability and success rates of drug development, and in doing so, improve the lives of patients with grievous illnesses. The Translational Medicine team contributes to drug development from the time a prototype molecule is identified through early clinical studies. It helps shape and refine the therapeutic candidate profile, formulate and execute biomarker and patient stratification strategies, and oversee a multi-functional effort to safely introduce new agents to patients across all therapeutic areas with the aim of efficiently advancing Amgen science into novel drugs. The Principal Analyst is part of Development IS team, which focuses on implementing and supporting innovative and GxP regulated systems and platforms for clinical trial design and execution, real world evidence generation & observational research, regulatory filings and pharmacovigilance. He/She will partner with the Translational Medicine team to design trials with innovative elements such as digital technologies and in vitro diagnostics, while focusing on rapid execution through demonstration of human proof of concept in a way that, if successful, enables seamless late-stage clinical development. The Principal Analyst will support a team consists of experienced physician-scientists working across the four therapeutic areas at Amgen -Cardiometabolic,Inflammation, Neuroscience, andOncology; a world-class clinicalpharmacologygroup; and innovative data scientists focused on digital health,clinical biomarkersand in-vitro diagnostics.

Key responsibilities of the Principal IS Analyst include:

• Develop deep understanding of preclinical study design and new innovative approaches of using digital technologies,clinical biomarkers, in vitro diagnostics, modelling and simulation, and real world evidence
• Define and implement the integrated data platforms, analytics, and AI (machine learning, NLP) capabilities required for enabling early stage molecules to late stage innovative drugs
• Lead requirements and design in close collaboration with Translational Medicine, and other Research and Global Development business organizations and IS teams
• Lead multi-functional teams to implement data platforms, data integrations, modeling and analytics tools using newest technologies and leveraging the enterprise city planning platforms
• Ensure sound architecture and design, provide technical oversight and guidance to the team
• Ensure solutions are implemented in accordance to the IS SOPs and IS Security policies
• Participate In Translational Medicine business process improvement initiatives, data architecture and programming multidisciplinary project team meetings and serve as a technical advisor

Basic Qualifications
Doctorate degree and 2 years of Information Systems experience

OR

Masters degree and 6 years of Information Systems experience

OR

Bachelors degree and 8 years of Information Systems experience

OR

Associates degree and 10 years of Information Systems experience

OR
High school diploma / GED and 12 years of Information Systems experience

Preferred Qualifications
8+ years leading technical / analytics application development projects

Extensive software, database and / or analytical tool development experience

Experience with cloud technologies and big data platforms such as Apache Spark/Databricks

Experience with statistical languages such as R/SAS
Working knowledge of data modeling, machine learning

Working knowledge of one or more relevant industry data standards (e.g., CDISC SDTM,

CDISC ADaM, HL7 BRIDG)

Experience in various LIMS solutions supporting pre-clinical studies, and clinical pharmacology modeling and simulation systems

Experience in using data and analytics to inform clinical trial design

Experience working in a regulated environment
Good communication, collaboration, teamwork, and negotiation skills

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.