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外資系、グローバルの転職・求人情報なら[Bilingual Recruitment Solutions]

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Statistician, Statistics Group, Clinical Statistics, Japan Biometrics and DM

バイオ医薬品業界のグローバルリーダーである企業でのポジションです

職種データマネジメント/統計
給与 900 - 1500 万円
日付2019-06-07
業種製薬
勤務地東京
求人番号Job-00070211

会社概要:

This company is the world's leading biopharmaceutical company and are committed to applying science and their global resources to improve health and well-being at every stage of life. They strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them. They have a leading portfolio of products and medicines that support wellness and prevention, as well as treatment and cures for diseases across a broad range of therapeutic areas including an industry-leading pipeline of promising new products that have the potential to challenge some of the most feared diseases of our time, like Alzheimer's disease and cancer.

業務内容:

1. 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.
2. 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.
3. Be accountable for study/PMS level and submission level statistical deliverables on assigned projects.
4. Develop effective collaborations with others within clinical teams, partner lines (such as, PharmSci, SRM, Regulatory Affairs), and external regulatory, industry, professional and academic organizations.
5. Ensure that all study/PMS and project level statistical activities are conducted in compliance with relevant regulatory requirements and company standards.
6. Be up-to-date on SOP training and compliance with all company SOPs as required based on the assigned curriculum.
7. Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, Clinical Programming colleagues – for assigned studies/PMS and regulatory submissions.
8. Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects.
9. Comply with all statistics and quality processes and company data standards that are applicable to statistical outputs, and support processes that require statistical input.
10. Communicate and collaborate with global BU/RU statisticians on assigned projects.
11. Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
12. Participate in research on statistical methodology and its applications to clinical trials/PMS.

応募条件:

医薬品会社での開発、創薬
疫学の知識があれば、年齢や企業経験問わず


BRS Consultant

Koto Ikeda

Pharma

Tel: 03-6370-8015

  • データマネジメントリーダー

    Biostats work in a great company

    職種データマネジメント/統計
    給与 500 - 800 万円
    日付2018-07-20
    業種製薬
    勤務地東京
    求人番号Job-00061028

    概要:

    同社は、CROとして医薬品開発(臨床試験)を受託する部門と、CSOとして製薬企業における営業・マーケティング業務を受託する部門が合併しスタートすることになりました。臨床開発から販売までをフルサポートできる製薬メーカーのパートナーとして、数多くの企業よりご評価をいただいております。

  • 開発本部 統計解析

    Big Japanese company

    職種データマネジメント/統計
    給与 600 - 1000 万円
    日付2018-05-21
    業種製薬
    勤務地東京
    求人番号Job-00049231

    概要:

    各種医薬品の研究、開発、製造、仕入および販売をしております。

  • Medical Epidemiology & Statistics (医療統計・疫学スペシャリスト)

    Leading European Pharma

    職種データマネジメント/統計
    給与 600 - 1000 万円
    日付2018-05-23
    業種製薬
    勤務地東京
    求人番号Job-00042960

    概要:

    Our client is leading life science company with a strong Japan business.