Associate Director, Biostatistics (4)

CSL Limited

Multiple Locations
On-site
Statistical strategies for clinical trials
Regulatory submissions
Statistical deliverables
CSL Limited is seeking an Associate Director of Biostatistics to lead statistical contributions for clinical development programs. The role requires significant experience in drug development, statistical strategy formulation, and regulatory submissions, while offering a dynamic and inclusive workplace

Job Summary

  • Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
  • Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
  • Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA).

Matching Summary

Match Score: 85

CSL Limited is seeking an Associate Director of Biostatistics to lead statistical contributions for clinical development programs. The role requires significant experience in drug development, statistical strategy formulation, and regulatory submissions, while offering a dynamic and inclusive workplace.

Skills & Requirements

Must-have

  • statistical strategies for clinical trials
  • regulatory submissions
  • statistical deliverables
  • SAS and/or R
  • advanced statistical methodologies

Nice-to-have

  • track record of innovation
  • interactions with major regulatory authorities
  • managing internal deliveries

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
  • leading roles in regulatory submissions

Work Rights

Not specified

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