About the job
What you'll do
Lead the statistical strategy and design for late-stage clinical trials and regulatory submissions across multiple therapeutic areas. Act as the primary statistical authority, overseeing CRO deliverables and interacting with health authorities like the FDA, EMA, and MHRA.
What they're looking for
Requires a postgraduate degree in Statistics or Biostatistics with extensive experience in late-phase pharmaceutical trials and regulatory approvals. Proficiency in SAS or R and a deep understanding of ICH and CDISC standards are essential.
Full description