Biostatistics Manager

This position is responsible for providing statistical expertise and leadership for clinical development and regulatory filing activities in Japan as a member of Global Biostatistical Science Japan Biostatistics. The role will focus primarily on Japan-specific submission-related activities, including new drug application in Japan, interactions with health authorities, document preparation such as CTD, and Japan-specific analyses and interpretations. Working closely with global and Japan cross-functional teams, this position will plan and execute the statistical strategies, analyses, documents, and regulatory responses required in Japan with a high level of quality.