Job Purpose

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.

Key Responsibilities

**Formulation and Execution of Statistical Strategy and Scientific Rationale for Clinical Development and Regulatory Submission Activities in Japan**

+ Contribute statistical input from the biostatistical perspective to Japan development s...