Associated Director, Biostatisticis, Japan

Century Center

Not specified (assumed hybrid based on typical industry practices).
5 years clinical development experience
Sas statistical programming proficiency
Cdisc sdtm and adam submission knowledge
The Associated Director, Biostatistics position at CSL Behring in Japan focuses on providing statistical expertise for clinical trials and regulatory submissions. The role requires collaboration with global teams and adherence to PMDA requirements while managing the quality and timeliness of statistical deliverables

Job Summary

  • The Statistical Scientist is accountable for implementing statistical strategies for clinical trials and regulatory submissions in Japan.
  • This role requires managing outsourcing operations and ensuring the quality of CRO deliverables while supporting interactions with the PMDA.
  • The position involves collaborating with the global CSL team on global study designs and stand-alone studies conducted specifically in Japan.

Matching Summary

Match Score: 85

The Associated Director, Biostatistics position at CSL Behring in Japan focuses on providing statistical expertise for clinical trials and regulatory submissions. The role requires collaboration with global teams and adherence to PMDA requirements while managing the quality and timeliness of statistical deliverables.

Skills & Requirements

Must-have

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

Nice-to-have

  • Japan native speaker preference
  • Rare disease sample size expertise
  • GCP inspection leadership experience
  • Matrix environment collaboration skills
  • Advanced statistical methodology training

Key Requirements

  • PhD or MS in Biostatistics or Statistics
  • Minimum 5 years pharmaceutical/biotech experience
  • Strong verbal and written English and Japanese communication
  • Experience with GCP inspections and data science areas

Work Rights

Not specified

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