[Japan] 統計解析マネージャー

To keep abreast of and analyze innovative statistical methods and various statistical issues in clinical trials, as well as the latest developments in regulatory authorities and industry, and to reflect them in clinical trial planning and practice as necessary.

Participate in the study planning process from an early stage to develop scientifically appropriate study designs and protocols, and to ensure and improve the quality of clinical trials.

Lead and conduct clinical trials and exploratory clinical research from statistical point of view, ensuring scientifically sound interpretation of clinical trials and exploratory clinical research and appropriate application of statistical methodologies.

Lead the discussion related study design, statistical methodologies including “Estimand Framework” and interpretation of study results for Ph2b/Ph3 with authority (PMDA) Communicate effectively with stakeholders about clinical trial plans or results, both orally and in writing.