• Sr. Biostatistician

    Job Locations US-WA-Seattle
    Job ID
    2018-1292
    Category
    Clinical & Medical Affairs
  • Overview

    The Senior Biostatistician applies statistical methodologies to clinical and research datasets; assists in protocol design; develops statistical analysis plans; drafts presentations of statistical findings and methods; communicates results to internal and external customers; and provides leadership within the Biometrics function.

     

     

    Responsibilities

    • Contributing to the development of study protocols, in particular, the statistically-related sections (e.g. sample size calculations, statistical methodology, and statistical analyses).
    • Identifying the most appropriate analytical models/methods for clinical studies, and conducting research on statistical methodology, as needed, to accomplish this responsibility.
    • Participate in developing detailed statistical analysis plans; independently assess the appropriate statistical methodology for data analysis.
    • Participate in database design meetings to ensure that data are free of bias, contain maximum information (minimum variance), and satisfy analytical requirements. And review Case Report Forms (CRFs) to ensure that all relevant data necessary to planned analyses is captured.
    • Analyzing data and interpreting results from studies to meet objectives of the study protocol, and business and publication objectives; independently apply and implement basic and complex techniques to these analyses.
    • Preparing oral and written reports to effectively communicate results of clinical trials to the project team, senior management, regulatory agencies and/or individual investigators and other external reviewers of clinical trials data.
    • Ensure the scientific integrity of the statistical methodologies applied in and findings reported in clinical trials.
    • Participate in cross functional teams supporting the conduct of clinical trials and provide the statistical perspective on those teams. 
    • Communicating effectively with regulatory agencies, in meetings and in written material (e.g. briefing documents) the statistical methodologies and analyses conducted and provide interpretation of the results generated during clinical studies.

    Qualifications

    • PhD/MS degree in Statistics, Biostatistics, or related field and at least 8 to 10 years of relevant experience in the pharmaceutical/biotech industry.
    • High level of personal motivation and the ability to work independently.
    • Proficiency in SAS Analytics programming
    • Ability to provide cross functional support within Clinical and Regulatory Affairs and other departments, as needed.

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