Project Statistician /統計解析/データマネージメント 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬
最終更新日: 2019年 05月 20日





Project Statistician 

Collaborate with data management in the planning and implementation of data quality assurance plans.


・臨床開発医師をはじめとしたMedicalの同僚とともに、臨床開発計画やプロトコルのデザイン、解析計画の策定 や支援を行う。

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.


  • ・臨床開発、疫学その他関連領域における統計的手法に関する知識
    ・ SAS言語での高いプログラミング能力が好ましい

    ・M.S., Ph.D., or equivalent experience in Statistics, Biostatistics, or equivalent of field study
    ・Ph.D. more preferable
    ・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

    ・Experiences of collaboration with team outside of Japan (preferred: overseas living experience)
    ・Proficient in the SAS programming language


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