Sr Scientist-Clinical Pharmacology-Modeling & Simulation

Employer
Amgen
Location
Thousand Oaks, California
Posted
Sep 07, 2018
Ref
R-62840
Required Education
Doctorate/PHD/MD
Position Type
Full time

Amgen Clinical Pharmacology Modeling and Simulation (CPMS) is seeking a Senior Scientist who will serve as a Pharmacokinetics/Pharmacodynamic (PK/PD) modeler (ie, pharmacometrican) to support Amgen Development and Translational Sciences programs across multiple therapeutic areas of oncology/hematology, cardiovascular disease, inflammation, bone health, nephrology and neuroscience.

Key responsibilities of the Senior Scientist include:

  • Responsible for creation and execution of Modeling and Simulation (M&S) plans that include conducting
  • PK/PD analyses for small and large molecules from early to late drug development phase using pharmacostatistical modeling techniques
  • mechanistic modeling for translational biomarkers
  • meta-analysis using literature data
  • clinical trial simulations to support dose selection, study design, and drug development decisions
  • Lead author for PK/PD reports and contribute to the summary documents for regulatory submissions.
    Participate in cross-functional project teams and provide scientific input.
    Contribute to clinical pharmacology plan by establishing high impact M&S strategy for the program(s)
    Responsible for responses to questions from regulatory reviews.

Basic Qualifications

Doctorate degree and 2 years of Pharmacokinetics/Pharmacodynamic or statistical modeling experience
OR
Master's degree and 5 years of Pharmacokinetics/Pharmacodynamic or statistical modeling experience
OR
Bachelor's degree and 7 years of Pharmacokinetics/Pharmacodynamic or statistical modeling experience

Preferred Qualifications

  • PhD in applied (bio)statistics, applied biomathematics/biophysics, (bio)engineering or related fields with equivalent professional degrees (e.g. MD, PharmD) with 3 years of PK/PD or statistical modeling experience
  • Experience in analyzing PK/PD and/or clinical trial data using advanced pharmacometric or statistical modeling methodologies
  • Experience in conducting clinical trial simulations to assist study designs
  • Proficiency in modeling software (e.g. NONMEM, SAS, R/S-Plus, STAN, MATLAB)
  • Excellent interpersonal, technical, and communication skills
  • Previous record of scientific contributions through peer-reviewed articles and external presentations

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