Principal Biostatistician


Principal Biostatistician

Job Locations(All) | US-Remote

Overview

Principal Biostatistician

Responsibilities:

  • Serves as the lead biostatistician on programs of studies or submissions, or on simple to complex individual studies.
  • Serves as an independent reporting statistician on data monitoring committees.
  • Develops statistical analysis plans and reporting specifications for simple to complex clinical studies.
  • Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
  • Performs senior review of TFLs and statistical analysis plans.
  • Provides significant input in the development and review of CRFs, edit specifications, and critical variable lists.
  • Performs lead review of TFLs and derived datasets for clinical studies.
  • Contributes to clinical study protocols and clinical study reports.
  • Reviews simple to complex randomization specifications and dummy randomization schemes.
  • Trains and mentors new or junior statisticians on statistical methods and PRA procedures.
  • Provides statistical training at monthly seminars.
  • Participates in bid defense meetings.

Qualifications:

  • Master’s degree in statistics or biostatistics required.
  • Minimum of 8 years of biostatistical experience desired.
  • Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures, and good programming practices.
  • Demonstrates ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials.
  • Displays excellent communication skills with demonstrated leadership ability.


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PRA Health Sciences

PRA
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