Senior Biostatistician

日本 外資系企業 外資系企業
  • Design and Execute Biostatistic Aspects of Clinical Studies in Japan
  • Lead Team of Statisticians on a Project Basis

企業情報

  • Well known global biopharmaceutical company with rich development pipeline and diverse product portfolio in oncology, infectious disease, immunology, CNS

職務内容

  • Responsible for directing the biostatistics activities in collaboration with HQ, from trial design, execution, analysis, and data interpretation.
  • Serve as regional subject matter expert for specific programs and TAs and provides leadership to support all clinical studies, regulatory submissions, and publications for the program or therapeutic area.
  • Participate in development of clinical study protocols, including experimental design, specification of analysis endpoints, determination of sample size, and specification of methods of statistical analysis.

  • Participate in the design of case report forms and reviews data validation specifications and other data management documentation associated with clinical study database development.

  • Develop, review and approve statistical analysis plans.

  • Research, develop and implement statistical methods appropriate to clinical study design and objectives and consistent with current regulatory standards and requirements.

  • Design the layout and content of tables, figures, and listings in accordance with statistical analysis plans.

  • Participate in regulatory submission planning, including data submission strategies and the creation of integrated summaries.

  • Represent company in discussions and meetings with regulatory agencies.

  • Plays a key role in the development of biostatistics processes and procedures, including the writing and review of department standard operating procedures.

理想の人材

  • Ideally MS or PhD in Statistics, or equivalent amount of experience the pharmaceutical industry including design, analysis, and reporting of clinical studies.
  • Significant experience with regulatory submissions and interactions with regulatory agencies.
  • Extensive experience with the design, analysis, and reporting of Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting.
  • Demonstrated leadership skills as biostatistics lead on multiple clinical programs.
  • Hands-on experience with developing detailed statistical analysis plans and designing tables, figures, and listings for clinical study reports.
  • Knowledge of current topics and issues related to the design and analysis of clinical studies, including adaptive designs, multiplicity, handling of missing data, and sensitivity analyses.
  • Strong oral and written communication, as well as problem-solving skills, are essential; ability to proactively identify issues and determine appropriate solutions to complex problems.
  • Excellent working knowledge of the SAS software package; ability to communicate effectively with SAS programmers, review SAS output, and write SAS code as needed.
  • Strong working knowledge of current regulatory requirements related to the submission of clinical study data and statistical programs.
  • Experience in the development of integrated summaries of safety and efficacy. Demonstrated expertise in implementation of CDISC standards applicable to regulatory submissions.
  • Ability to handle multiple projects at one time and direct resources appropriately to address frequent changes in priorities.
  • Fluent English and Japanese skills

条件・待遇

  • Opportunity to lead biostatistics projects at a country level within a major global biopharmaceutical company
コンタクト
Ed Marsden
求人番号
4204966
電話
+813 6832 8981

求人情報

勤務地
雇用形態
担当コンサルタント
Ed Marsden
担当コンサルタントの電話番号
+813 6832 8981
求人番号
4204966
企業タイプ