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  • 04 Sep 2020

    [生物統計副處長] Clinical Biostatistical Associate Director

    Taiwan

    Permanent Position
    A Taiwanese local biotech_Independent research and development of new military drugs, clinical trials, cGMP manufacturing, and commercial mass production are all in Taiwan

    Job Description

    1. Utilizing your expertise to conducting and supporting internal SOPs standards, and managing technical quality and consistent approaches in clinical study design and statistical analysis strategically.
    2. Providing input for clinical publications, Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overviews and regulatory documents.
    3. You need to plan and execute statistical contributions to Clinical Study Protocols and Clinical Study Reports.
    4. Collaborate with your vendors and colleague, you need to leading the team to perform statistical and exploratory analysis of clinical studies/projects and developing conclusions and recommendations.
    5. Anticipating and communicating resource and quality challenges that could impact deliverables or timelines.
    6. Ensuring the process improvements and operational efficiencies.
    7. Support PV (Drug Safety) function to maintain their safety data preparation and regulatory submission.
    Expires on 04 Oct 2020

    Posted By

    Steven Yang

    Tel: +886 987 957 235

    stevenyang@peoplesearch.jobs

    Requirements

    1. Possesses over 5 years' experience in the Pre-clinical Development, Clinical Development and Post-marketing) filed. 
    2. Obtain strong statistical leadership and contribution to regulatory and reimbursement submissions.
    3. Experience working effectively in a globally dispersed team(US, EU, JP, CN is a preferred) environment with cross-cultural partners.
    4. Experience with data management and PV, especially in having experience of using SAS, SPSS, ADMOS,Argus will be a plus.

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