Associated Director, Biostatisticis, Japan

CSL

Tokyo, JP
**
5 years clinical development experience
Sas statistical programming skills
Pmda submission requirements knowledge
** CSL is seeking an Associate Director of Biostatistics in Tokyo, Japan, to lead statistical contributions to clinical development programs and ensure compliance with PMDA requirements. The ideal candidate will possess a PhD or MS in Biostatistics and have at least five years of experience in a pharmaceutical or biotechnology setting. **

Job Summary

  • The role supports the Japan clinical team with statistical expertise and ad hoc analyses for PMDA requests.
  • Candidates will collaborate with the global CSL team on designing global studies including those conducted solely in Japan.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies.

Matching Summary

Match Score: 75

** CSL is seeking an Associate Director of Biostatistics in Tokyo, Japan, to lead statistical contributions to clinical development programs and ensure compliance with PMDA requirements. The ideal candidate will possess a PhD or MS in Biostatistics and have at least five years of experience in a pharmaceutical or biotechnology setting. **

Skills & Requirements

Must-have

  • 5 years clinical development experience
  • SAS statistical programming skills
  • PMDA submission requirements knowledge
  • CDISC SDTM and ADaM standards
  • CRO management and oversight

Nice-to-have

  • Rare disease sample size expertise
  • Global study design collaboration
  • GCP inspection leadership experience
  • Advanced statistical methodology training
  • Strong English and Japanese communication

Key Requirements

  • PhD or MS in Biostatistics or Statistics
  • Japan native preferred
  • Overseas travel capability to USA

Work Rights

Not specified

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