(Sr.) Manager, Statistics / Sr Clinical Statistician
Core
Lead statistical analysis and regulatory submission strategies for clinical trials to ensure scientifically robust evidence for safe medicine use.
Role type
Senior IC clinical statistician (manager level)
Builds
Clinical trial results, top-line trial reports, meta-analysis results, and regulatory submissions
Domain
Pharmaceutical clinical research / Biostatistics
Required skills
Experimental design, statistical analysis planning, regulatory submission strategy, scientific report generation, cross-functional collaboration, independent decision-making in ambiguous situations, literature comprehension
Preferred skills
Biostatistical methodologies, regulatory interaction experience, project management, AI tool utilization (generative AI), therapeutic area expertise
Technologies
Statistical software (implied by domain), Generative AI tools (ChatGPT, Microsoft Copilot)
Responsibilities
Provide statistical inputs to study designs and analysis plans; deliver statistical analyses and scientific reports for regulatory submissions; support publication activities and regulatory queries; establish consistent methodologies within the therapeutic area; ensure compliance with regulatory requirements; spearhead intricate projects across business units
Seniority
Senior, hands-on IC with management responsibilities