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CSL Seqirus is seeking an Associate Director of Biostatistics in Tokyo, Japan, to lead statistical contributions for clinical development programs, particularly in collaboration with the Japan clinical team and in compliance with PMDA requirements. The ideal candidate will have extensive experience in statistical analysis within pharmaceutical settings, strong communication skills in both Japanese and English, and familiarity with regulatory submissions.
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Job Summary
The Statistical Scientist will provide statistical expertise to the Japan clinical team and support interactions with the PMDA.
Candidates must be accountable for the quality of statistical analysis plans and CDISC deliverables for regulatory submissions.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies.
Matching Summary
Match Score: 75
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CSL Seqirus is seeking an Associate Director of Biostatistics in Tokyo, Japan, to lead statistical contributions for clinical development programs, particularly in collaboration with the Japan clinical team and in compliance with PMDA requirements. The ideal candidate will have extensive experience in statistical analysis within pharmaceutical settings, strong communication skills in both Japanese and English, and familiarity with regulatory submissions.
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Skills & Requirements
Must-have
5 years clinical development experience
SAS statistical programming proficiency
CDISC SDTM and ADaM knowledge
PMDA submission requirements expertise
CRO management and oversight skills
Nice-to-have
Japan native speaker preferred
Experience with rare disease sample size
Global study collaboration experience
GCP inspection leadership capability
Advanced statistical methodology training
Key Requirements
PhD or MS in Biostatistics or related field
Minimum 5 years in pharmaceutical/biotech clinical development
Strong verbal and written English and Japanese communication skills