Biostatistics Manager
Amgen · Tokyo, Japan
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Role summary
Amgen seeks a biostatistics manager in Tokyo to lead statistical strategy and execution for clinical development and regulatory submissions in Japan. The role involves collaborating with global and local teams to prepare regulatory documents, conduct Japan-specific analyses, and support interactions with health authorities. Candidates should hold a master's degree in biostatistics or statistics.
What they're looking for
- Master's degree in biostatistics, statistics, or related field
- 6+ years statistical experience in pharmaceutical, biotechnology, or medical research
- Proficiency with SAS, R, and/or Python statistical software
- Business-level fluency in Japanese and English
- Clinical trial methodology and regulatory authority interaction experience
- Cross-functional and global team collaboration skills
- Strong written and verbal communication abilities
What you'll be doing
- Develop and execute statistical strategies for Japan clinical development and regulatory submissions
- Prepare, review, and ensure quality of statistical documents including analysis plans and regulatory responses
- Evaluate statistical appropriateness of Japanese participant enrollment in multinational trials
- Provide statistical input on Japan-specific analyses and regulatory authority interactions with PMDA
- Lead or support clinical trial planning and execution as Study Lead or Study Statistician
Privacy & handoff
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