Biostatistician

Medpace Holdings, Inc.

Japan, Tokyo

Job Summary

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Biostatistician to join our Biostatistics team in Japan. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

• Contribute to clinical development plan preparation;• Review of study protocol and preparation of statistical methodologies;• Development of detailed Medpace Data Analysis Plan for assigned projects;• Programming of study analysis, review of study results and preparation of statistical methods section for clinical/statistical reports;• Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis; and• Communicate statistical results to medical writing personnel to ensure accurate interpretation.

Qualifications

  • Ph.D. degree in Biostatistics/Statistics with pharmaceutical clinical trial experience;
  • Strong experience in SAS® programming or equivalent;
  • Knowledge of other statistical software;
  • Knowledge of advanced statistical methods and knowledge of the pharmaceutical industry;
  • Knowledge of regulatory requirements/guidelines for drug development;
  • Familiarity with complex statistical methods that apply to Phase I-IV clinical trials;
  • Experience in generation of analysis databases, and analyses for medium to high complexity clinical trial projects including ISS, ISE, and electronic submissions;
  • Bilingual English and Japanese.

Job posted: 2023-12-18

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