• Biostatistics Asset Lead

    Job Locations (All) | US-Remote
    Posted Date 2 days ago(8/23/2019 8:02 AM)
  • Overview


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    Senior Principal Biostatistician – Biostatistics Asset Lead (BAL)




    Designs, plans, and executes biostatistical components of clinical trials. Uses sound statistical methodology to conduct studies, prepares the statistical components of protocols, and is responsible for the statistical components of reports.



    • 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 TLFs and statistical analysis plans.
    • Provides significant input in the development and review of CRFs, edit specifications, and critical variable lists.
    • Performs lead review of TLFs 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.


    • Master’s degree in Statistics or Biostatistics is required. PhD is preferred.
    • Minimum of 8 years of relevant biostatistical experience is required. The Biostatistics Asset Lead (BAL) will be at minimum a Principal-level Statistician.
    • Experience in regulatory submission/interaction is strongly preferred.
    • 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.


    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities.


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