Associated Director, Biostatisticis, Japan

CSL Behring

Japan
Not specified (assumed on-site due to the nature of the role and interactions with pmda).
5 years clinical development experience
Sas statistical programming expertise
Pmda cdisc submission requirements knowledge
CSL Behring is seeking an Associate Director of Biostatistics in Japan to provide statistical support for clinical development programs, specifically for submissions to the PMDA. The ideal candidate should have at least five years of experience in a pharmaceutical setting, strong knowledge of CDISC requirements, and fluency in both English and Japanese

Job Summary

  • The Statistical Scientist is accountable for implementing statistical strategies for clinical trials and regulatory submissions to the PMDA.
  • This role requires managing outsourcing operations and ensuring the quality of CRO deliverables while supporting global study designs including Japan-specific trials.
  • CSL Behring is a global biotherapeutics leader employing 32,000 people who delivers lifesaving therapies to over 100 countries.

Matching Summary

Match Score: 85

CSL Behring is seeking an Associate Director of Biostatistics in Japan to provide statistical support for clinical development programs, specifically for submissions to the PMDA. The ideal candidate should have at least five years of experience in a pharmaceutical setting, strong knowledge of CDISC requirements, and fluency in both English and Japanese.

Skills & Requirements

Must-have

  • 5 years clinical development experience
  • SAS statistical programming expertise
  • PMDA CDISC submission requirements knowledge
  • CRO management and oversight skills
  • Bilingual English and Japanese communication

Nice-to-have

  • Experience with rare disease sample size calculations
  • Advanced training in statistical methodologies
  • Matrix environment leadership capabilities
  • GCP inspection preparation experience
  • Global study design collaboration

Key Requirements

  • PhD or MS in Biostatistics or Statistics
  • Minimum 5 years pharmaceutical/biotech experience
  • Japan native preferred
  • Overseas travel capability to USA required

Work Rights

Not specified

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