求人番号:JN -072024-138848 掲載日:2024-09-11

Manager, Bio-Statistician

Global Company
1000 - 1300 万円 東京 製薬 データマネジメント / 統計解析

募集要項

会社概要
同社は医療用医薬品を研究・開発・製造・販売しています。
業務内容
  • Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects.
  • Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports (topline reports, clinical study reports, etc.), including clinical trial/PMS results, support for publication activities, scientific presentations, and support to responses to queries from regulatory authority.
  • Be accountable for study/PMS level and submission level statistical deliverables on assigned projects.
  • Develop effective collaborations with others within clinical teams, partner lines, external regulatory, industry, professional and academic organizations.
  • Ensure that all study/PMS and project level statistical activities are conducted in compliance with relevant regulatory requirements and standards.
  • Be up-to-date on SOP training and compliance with all SOPs as required based on the assigned curriculum.
  • Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, data managers, clinical programming colleagues – for assigned studies/PMS and regulatory submissions.
  • Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects.
  • Comply with all statistics and quality processes and data standards that are applicable to statistical outputs, and support processes that require statistical input.
  • Communicate and collaborate with global statisticians on assigned projects.
  • Provide a strong statistical presence in regulatory and professional circles.
  • Participate in research on statistical methodology and its applications to clinical trials/PMS.
  • 応募条件
    Experience:
    • At least 3 years of experience in biostatistics for clinical development or post-marketing in drug industry or equivalent

    Education/Certification:

    • Advanced degree in statistics, biostatistics, or related field

    Language:

    • Written and oral communication skills in English to effectively communicate with global statisticians


    Technical Skills:

    • Strong statistical/epidemiological skills with application to clinical trials/PMS
    • A broad understanding of drug development
    • Knowledge of clinical medicine and regulatory requirements

    Behavioral Skills:

    • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization

    Consulting skills:

    • Capability to provide statistical leadership to cross-functional teams


     
    給与
    1000 - 1300 万円
    勤務地
    東京
    Martin Tsvetkov
    BRSコンサルタント
    Martin Tsvetkov
    Pharma
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