Available Positions

Sr. Clinical Modeling & Simulation Consultant at Pharmaceutical Company in Massachusetts, Massachusetts, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • Massachusetts, Massachusetts, United States
  • 10/10/19

Job ID: 60436

Job Description

The clinical modeling and simulation (MS) team is responsible for implementation of emerging quantitative methodology to support decisions in clinical development and regulatory submission. MS personnel work closely with regulatory affairs, medical science, clinical pharmacology, safety, and translational science groups to deliver high quality modeling and simulation results. 

This position is a hands-on position responsible for the development and execution of MS strategies and delivering analyses results for decision making in clinical development. The position will contribute to strengthening MS technical skillset, computational infrastructure, and utility of MS in clinical development.

 

Roles and Responsibilities:

  • Develop and execute MS strategies integrated with preclinical and clinical development
    • Contribute to decision making at critical milestones in collaboration with statistics, clinical pharmacology, medical, research and translational science groups
    • Perform population PK, PKPD, clinical trial simulation and other model-based analyses

Qualifications

  • Basic Qualifications:
    • 7+ years of pharmaceutical industry experiences in quantitative disciplines of clinical pharmacology, pharmacometrics, statistics, or QSP
  • Preferred Qualifications:
    • Excellent hands-on knowledge in R, NONMEM, and/or MONOLIX
    • Track record of applying quantitative tools in clinical development
    • Track record of publication in MS
    • Fluency in English, with excellent written and oral communication skills

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