Biostatistics Manager

Amgen
📍 Tokyo, Japan, Japan 💼 Full-time 🕒 Posted June 24, 2026

Job Description

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...

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Job Details

  • Location Tokyo, Japan
  • Job Type Full-time
  • Category other-general
  • Posted Date June 24, 2026
  • Application Deadline June 29, 2026