ERT

  • Principal Biostatistician

    Job Location US-NY-Pittsford
    Shift
    Regular
    Type
    Regular Full-Time
  • Overview

    The Principal Biostatistician is responsible for reviewing study Protocols, developing Statistical Analysis Plans, and interpreting analysis for the Safety Reports.  The Principal Biostatistician works closely with the Scientific Team and the Statistical Operations Manager to update the standard methodology in order to keep current with industry recommendations.

    Responsibilities

    • Develop the Statistical Analysis Plan (SAP) for analysis to be performed at ERT.
    • Review study protocols, and synopsis and provide consultation to sponsors on study design, sample size, and statistical methodology.
    • Provide consultation on teleconferences with sponsors, including detailed descriptions, and interpretations of statistical analysis and methodologies.
    • Develop reports of statistical analysis results in conjunction with the Scientific Team and Medical Writer.
    • Review and QC outputs of tables, figures, and listings from statistical analysis to ensure consistency with the methodology outlined in the statistical analysis plan.
    • Research and develop new techniques for statistical analysis to drive industry recommendations.
    • Research and implement existing analysis techniques for new service lines.
    • Support research programs and provide research results to the team.
    • Drive ideas for future analyses and data quality efforts.
    • Provide creative solutions to problems under time constraints.
    • Provide training and guidance to less experienced staff.

     

    Qualifications

    Education:

     

    • PhD in Statistics, Mathematics or equivalent with 6+ years of relevant industry experience.
      or
    • Master’s degree in Statistics, mathematics or equivalent with 10+ years of relevant industry experience.

     

     

    Experience:

     

    • At least 6+ years of previous experience in statistical modeling for clinical trials.
    • Familiarity and experience with ANOVA, t-test, regression, and linear mixed-effects modeling.
    • Strong communication skills
    • Familiarity with ERT products and service lines.
    • Computer competencies to include Microsoft Outlook, Word, and Excel.
    • Strong SAS and R programming skills.
    • Ability to learn quickly, function independently, and handle increasing levels of responsibility.

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