Associated Director, Biostatisticis, Japan

Seqirus

Japan
5 years clinical development experience
Sas statistical programming proficiency
Pmda regulatory submission knowledge
The role involves providing statistical strategies for clinical trials and regulatory submissions to the PMDA in Japan

Job Summary

  • The role involves providing statistical strategies for clinical trials and regulatory submissions to the PMDA in Japan.
  • Candidates must manage outsourcing operations and ensure the quality of CRO deliverables for global and stand-alone studies.
  • The position requires strong communication skills in both English and Japanese to collaborate with global teams and local authorities.

Matching Summary

The role involves providing statistical strategies for clinical trials and regulatory submissions to the PMDA in Japan.

Skills & Requirements

Must-have

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

Nice-to-have

  • Rare disease sample size calculation
  • GCP inspection leadership experience
  • Global matrix environment collaboration
  • Advanced statistical methodology training
  • Japanese native speaker preference

Key Requirements

  • PhD or MS in Biostatistics or Statistics
  • Minimum 5 years in pharmaceutical clinical development
  • Native Japanese language capability preferred
  • Experience with CDISC standards for PMDA

Work Rights

Not specified

Tailored Resume

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