Scientist- Clinical Pharmacology, Modeling and Simulation
Amgen is seeking a Scientist-Clinical Pharmacology who will be located in our Thousand Oaks, CA location.
As part of the Clinical Pharmacology, Modeling and Simulation department, the Modeling and Simulation Scientist will support Amgen clinical development and translational sciences programs across multiple therapeutic areas with emphasis on oncology/hematology and nephrology.
Responsibilities of the Scientist include:
- Building pharmacostatistical models to support Pharmacokinetics/Pharmacodynamic (PKPD) and exposure-response analyses using relevant state of the art modeling and simulation techniques.
- Training in binary and categorical and binary data analyses, time-to-event (hazard) models, Poisson models, MCMC and Bayesian methods as applied to exposure-response analyses and Population PK and PKPD analysis.
- Perform meta-analysis using proprietary and/or literature data.
- Participate in cross-functional project teams and provide scientific input for dose selection, early and late study designs using modeling and simulation inputs.
- Contribute to clinical pharmacology strategy for the program(s) and implement project plans.
- Generate modeling reports and contribute to the summary documents for regulatory submissions.
Master's degree and 4 years of scientific experience
Bachelor's degree and 6 years of scientific experience
- PhD, MD or PharmD in applied statistics/mathematics, biostatistics, engineering, or pharmaceutical sciences
- 2 years industry or relevant academic experience in applied biostatistics or pharmacometric analyses of small molecules and/or biologics.
- Proficiency in modeling software (e.g. R, SAS, NONMEM, STAN, MATLAB)