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  • 16 Feb 2019

    【研究開発本部バイオメトリクス】 Project Statistician (担当/担当課長/専門課長)

    Japan

    Permanent Position
    アメリカ系製薬企業 - 1876年に創業、140年を超える歴史がある。米国インディアナ州インディアナポリスに本社を置く、革新を追求する医薬品のリーディング・カンパニーです。世界各国の自社研究施設や外部の優れた科学的研究機関との提携による最新の研究成果を用いて、各治療領域で最高レベルの豊富なポートフォリオの医薬品を開発しています。世界120ヵ国以上で事業を展開しています。

    Job Description

    【職務概要/Overall Job Purpose】
    Provide strong statistical leadership in the process of drug development.
    The Project statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.


    【主な職責/Primary responsibilities】
    Statistical Trial Design and Analysis
    ● Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
    ● Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.
    ● Collaborate with data management in the planning and implementation of data quality assurance plans.
    ● Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
    ● Participate in peer-review work products from other statistical colleagues.

    Communication of Results and Inferences
    ● Collaborate with team members to write reports and communicate results.
    ● Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
    ● Respond to regulatory queries and to interact with regulators.

    Therapeutic Area Knowledge
    ● Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.

    Regulatory Compliance
    ● Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training. 

    Expires on 18 Dec 2019

    Posted By

    Miki Nagai ((少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 下記のメールアドレスまでご送付いただけますとスムーズです。) Tel: 080-1118-4497 nagai.m@peoplesearch.jobs)

    Tel: 080 1118 4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須経験(Required Experience (mandatory for hiring)】
    ◆ M.S. or Ph.D. in statistics or biostatistics.
    or
    ◆ Rich experiences in healthcare field as a statistician with science background such as mathematics or epidemiology.

    ◆ Ph.D. more preferable


    【望ましい経験/Desirable Experience】
    ◆ Experiences of collaboration with team outside of Japan (preferred: overseas living experience)


    【必須応募資格/Essential skills and license (mandatory for hiring)】
    ◆ Statistical and methodological knowledge in clinical development, epidemiology or related field.
    ◆ Regulatory knowledge of clinical trial methodology and statistics. 
    ◆ Ability to build relationships with individuals and teams.
    ◆ Strong English and Japanese communication and presentation skills


    【望ましい資格/Desirable skills and license】
    ◆ Proficient in the SAS programming language 

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