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  • Posted: Nov 20, 2020
    Deadline: Not specified
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    Synteract is an innovative CRO providing full-service, Phase I-IV services to biopharma companies in bringing new medicines to market. We align our operational excellence, therapeutic expertise and the right technology to support each clients clinical development needs. Over its nearly 30-year history, Synteracts leadership has been proven in the core dev...
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    Biostatistician

    Position Overview

    The Biostatistician plans and conducts the summaries and analyses of data for assigned clinical studies. Works closely with the Sponsor, clinical team, project manager, data manager, other Biostatisticians, and programmers to analyze and present the data based on Sponsor specifications. Creates, verifies/validates, maintains, and reviews the statistical analysis code and the tables, listings, figures, and analysis outputs for assigned studies in compliance with standard operating procedures and relevant regulatory guidance.

    Specific Tasks Would Include

    • Maintain responsibility for assigned tasks: ensure on-time delivery, communicate the status of tasks to internal teams, provide quality control of work produced by others, and ensure statistical analysis is being done according to specifications.
    • Read and understand the protocol, statistical analysis plan, and other relevant study documentation for assigned studies.
    • Provide sample size calculations and documentation for simple studies.
    • Generate randomization schedules and kit lists.
    • Review case report forms for assigned studies to ensure data is collected appropriately to achieve the analysis defined in the protocol.
    • Contribute to statistical analysis plans and produce mock table and listing shells.
    • Review specifications for derived data sets.
    • Create programming code for inferential analyses, and ensure programming is being done according to Synteract SOPs and Sponsor expectations.
    • Review tables, listings, figures, and analysis output.
    • Perform bibliography research for statistical analysis techniques

    Degree And Experience

    • Master's degree or equivalent in statistics, mathematics or related field of study and some related experience or equivalent combination of education and experience.

    Specific Knowledge

    • Possesses a basic understanding of statistical methods relevant to clinical trials.
    • Understands the conduct and analysis of clinical trials.
    • Possesses a basic knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
    • Proficiency in BASE SAS or other statistical software is advantageous but not required.

    Method of Application

    Interested and qualified? Go to Synteract on www.synteract.com to apply

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