Modeling and Simulation - Principal Statistician

Employer
Amgen
Location
Thousand Oaks, California
Posted
Aug 31, 2018
Ref
R-62500
Required Education
Doctorate/PHD/MD
Position Type
Full time

Simulation and Modeling Principal Statistician is a biostatistician with solid experience in leading clinical trial design, execution, analysis and reporting; and excellent technical expertise in modeling and simulation. This role works closely with Director, Statistical Innovation (DSI), Strategic Development Director (SDD), EGTs and study teams throughout the evidence generation planning and study design process. This role is accountable for the development and execution of the simulation plan based on design options and simulation specifications provided by DSI, SDD and study teams; and deliver simulation reports under the guidance from DSI.

  • Participates in discussion sessions of EGP development and study design to ensure understanding of the clinical trial design options and collect design inputs from DSI, SDD and study team
  • Works with DSI to develop and finalize simulation plan with detailed specifications and operating characteristics that enable the evaluation and selection of the optimal design options
  • Executes simulation plan and summarizes results in outputs in presentation ready visualization
  • Works with DSI to evaluate design options and form design recommendations and finalize simulation report
  • Participates in sessions to present simulation results and recommendations to the product/study team
  • Leads the development of modeling and simulation tools
  • Supports the promotion of innovative designs and analysis methods by contributing to or providing internal training sessions
  • Provides training and team leadership to Modeling and Simulation junior statisticians when needed

Basic Qualifications

Doctorate degree and 2 years of Statistical Modeling and Simulation experience
OR
Master's degree and 6 years of Statistical Modeling and Simulation experience
OR
Bachelor's degree and 8 years of Statistical Modeling and Simulation experience

Preferred Qualifications

  • Master's degree in Statistics/Biostatistics or related subject with high statistical content with 6 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, execution, analysis and reporting; or
  • Doctorate in Statistics/Biostatistics with 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research
  • Experience in designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
  • Excellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc.
  • Proactive and efficient in learning emerging adaptive designs and building simulation tools for wide use and applications
  • Independent work on project planning and execution
  • Knowledge of Bayesian statistics
  • Extensive knowledge of simulation and modeling techniques
  • Work well with both statistical colleagues and cross functional teams
  • Good communication skills (written and oral)