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CSL Limited is seeking an Associate Director of Biostatistics to lead statistical contributions for clinical development programs, focusing on regulatory submissions and statistical methodologies for clinical trials. The ideal candidate should possess a PhD or MS in Biostatistics or a related field, along with substantial experience in drug development, regulatory interactions, and advanced statistical methodologies.
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Job Summary
The Associate Director, Biostatistics, leads the full scope of statistical contribution to a clinical development program.
This role involves defining statistical strategies for clinical trials and regulatory submissions, and is accountable for statistical deliverables within the program.
CSL Limited is a global biopharmaceutical company dedicated to helping patients around the world lead better, healthier lives.
Matching Summary
Match Score: 75
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CSL Limited is seeking an Associate Director of Biostatistics to lead statistical contributions for clinical development programs, focusing on regulatory submissions and statistical methodologies for clinical trials. The ideal candidate should possess a PhD or MS in Biostatistics or a related field, along with substantial experience in drug development, regulatory interactions, and advanced statistical methodologies.
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Skills & Requirements
Must-have
statistical strategy development
clinical trial design and analysis
regulatory submission support
cross-functional team collaboration
SAS and/or R proficiency
Nice-to-have
innovative study design
interaction with regulatory authorities
CRO management experience
track record of innovation
Key Requirements
PhD or MS in Biostatistics, Statistics or related field
PhD with 8 years of experience or MS with 11 years of experience in drug development
Statistical leadership at compound/indication level
Experience in regulatory submissions
Experience with major regulatory authorities preferred