Scientist-Clinical Pharmacology, Modeling and Simulation
Posted on: 18 Jan 2021
South San Francisco, CA
Job Description
Amgen is seeking a Scientist-Clinical Pharmacology who will be located in our San Francisco, 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.
Basic Qualifications:
Doctorate degree completed by August 2018
OR
Masters degree and 4 years of scientific experience
OR
Bachelors degree and 6 years of scientific experience
Preferred Qualifications:
* 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)
Amgen Inc.
Oakland, CA
Amgen Inc. discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of oncology/hematology, cardiovascular, inflammation, bone health, and neuroscience. The company’s products include Enbrel to treat plaque psoriasis, rheumatoid arthritis, and psoriatic arthritis; Neulasta, a pegylated protein to treat cancer patients; Prolia to treat postmenopausal women with osteoporosis; Aranesp to treat anemia; Xgeva for skeletal-related events prevention; Sensipar/Mimpara products to treat sHPT in chronic kidney disease; and EPOGEN to treat a lower-than-normal number of red blood cells.
It also markets other products in various markets, including Kyprolis, Nplate, Vectibix, Repatha, NEUPOGEN, Parsabiv, Blincyto, Aimovig, Imlygic, Corlanor, Kanjintitm, and Amgevitatm. Amgen Inc. serves healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies. It distributes its products through pharmaceutical wholesale distributors, as well as direct-to-consumer channels. The company has collaborative agreements with Novartis; UCB; Bayer HealthCare Pharmaceuticals Inc.; and DaVita Inc. Amgen Inc. was founded in 1980 and is headquartered in Thousand Oaks, California.
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IndustryManufacturing
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No. of Employees21, 500
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Website
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Jobs Posted662
