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  • Posted: Nov 9, 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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    Senior Biostatistician - South Africa

    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 guidances.

    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
    • Maintain responsibility for assigned studies: ensure on-time delivery, communicate the status of studies to internal teams and Sponsors, provide quality control of work produced by others, and ensure statistical analysis is being done according to specifications.
    • Review the protocol, statistical analysis plan, and other relevant study documentation for assigned studies and provide feedback.
    • Provide sample size calculations and documentation for more complex studies.
    • Serve as lead statistician for assigned studies, and coordinate and monitor work assignments of other supporting Biostatisticians.
    • Write statistical analysis plans and produce mock table and listing shells.
    • Work closely with internal teams and Sponsors to ensure high quality, timely deliveries of tables, listings, figures, statistical analyses, and reports.
    • Write statistical reports to summarize study results.
    • Review statistical results sections of clinical study reports.
    • Represent Biostatistics in communication with internal teams and Sponsors Contribute to the protocol for assigned studies by adding to the statistical methods section and providing input on study design issues, endpoint definitions, and sample sizes.
    • Serve as lead statistician for programs of studies and ensure consistency across multiple studies for a single Sponsor.
    • Provide a senior review of statistical analysis plans and mock table and listing shells for other Biostatisticians.
    • Provide a senior review of tables, figures, listings, and analyses for other Biostatisticians.
    • Serve as Independent Reporting Statistician for Data Monitoring Committees.
    • Provide statistical guidance and training for other Synteract Biostatisticians.
    • Participate in on-study and post-study audits.
    • Contribute to the business development process by participating in bid defences.

    Degree And Experience

    • Master's degree or equivalent in statistics, mathematics or related field of study and a minimum of 5 years related experience or equivalent combination of education and experience.

    Specific Knowledge

    • Possesses an intermediate understanding of a wide range of statistical methods relevant to clinical trials.
    • Understands the design, randomization, sample size calculation, conduct, analysis, and reporting of clinical trials.
    • Understands data management, programming, medical writing, and regulatory issues associated with clinical trials.

    Method of Application

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

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