← Back to opportunities
About the Role
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...
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...
Ready to Join Through a Referral?
Apply now and get connected directly with the hiring team
Apply for this Position