WuXi AppTec

  • Biostatistician I

    Job Locations CN-Shanghai
    Job ID
    2018-4163
  • Overview

    Plays a supportive role in the analysis, and reporting of clinical studies. Writes statistical analysis plans, performs statistical analyses, contributes to study reports, and interacts with other study team members.

    Responsibilities

    Support Lead ST on the following tasks:

    Develops statistical analysis plans and reporting specifications for clinical studies.

    • Develops and describes appropriate statistical techniques for the analysis of data in a statistical analysis plan.
    • Works with other statisticians on statistical methodology, study design, therapeutic area details, and data analysis.
    • Design appropriate shells and specifications for outputs.

    Performs statistical analyses and interprets results for clinical studies.

    • Develops or QCs analysis programs to implement techniques described in the statistical analysis plan.
    • Approves final database for freeze/lock.
    • Assesses model assumptions for statistical analyses.
    • Works with programmers, writers, and clinicians to coordinate data summarization and analysis activities, including summary statistics, tabulations, graphics, analysis output, and raw data listings.
    • Develops statistical reports and statistical sections of clinical study reports.

    Contributes statistical expertise to project teams for the analysis, and reporting of clinical studies.

    • Provides input into the preparation and review of clinical study protocols.
    • Creates dummy and final randomization schemes for clinical studies.
    • Participates in the development and review of CRFs, data edit specifications, and critical variable lists.

    Maintains, develops, and shares knowledge of company and industry procedures and methodologies.

    • Performs billable work in accordance with WuXi CDS’s policies, procedures, and SOPs.
    • Maintains solid knowledge of drug development process.
    • Maintains solid knowledge of SAS procedures and good programming practices.
    • Continues statistical training on new methods and techniques via self-study, internal training and courses, and external conferences and courses.
    • Develops knowledge of FDA and EMEA guidelines and requirements for reporting of clinical trials data.

     

    Qualifications

    Requirements for position

    • Master or PhD in Biostatistics, public health, statistics and related fields.
    • Strong expertise in Biostatics methodology.
    • Strong leadership, communication and cross-functional collaboration skills.
    • Excellent inter-personal and communication skills, ability to influence the key stakeholders.
    • Read, write and speak fluent English and Mandarin.

     

     
    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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