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The Principal Statistician will provide senior-level statistical expertise to support AAVantgarde Bio’s clinical development programs. This role combines hands-on statistical programming, advanced methodological expertise, and independent scientific judgement, working closely with cross-functional teams across Clinical, Medical, Regulatory, Data Management, and Biometrics. A strong focus will be placed on ophthalmology clinical trials and endpoints, ensuring analyses are scientifically rigorous, clinically interpretable, and aligned with regulatory expectations.
Job Responsibility:
Provide senior statistical expertise for the design, analysis, and interpretation of clinical trials across clinical development programs
Define statistical strategies including estimands, sample size, interim analyses, and analytical approaches
Perform hands-on statistical programming and review of analysis datasets, tables, figures, and listings
Apply advanced statistical methodologies and ensure alignment with regulatory expectations
Support the definition, analysis, and interpretation of ophthalmology-specific clinical endpoints
Ensure high-quality, accurate, and inspection-ready statistical deliverables
Collaborate closely with Clinical, Medical, Regulatory, Data Management, and Biometrics teams
Contribute to statistical sections of protocols, SAPs, clinical study reports, and regulatory documents
Act as a statistical thought partner, clearly communicating results and implications to non-statistical stakeholders
Requirements:
Senior-level expertise in clinical trial statistics within biotech or pharmaceutical environments