In a clinical trial, the project biostatistician’s role in blinded review is to evaluate data quality and finalize analysis decisions without knowledge of treatment assignments, ensuring scientific rigor while preserving the study blind.

Project Biostatistician’s Role in Blinded Review

• Blinded data assessment
• Reviews pooled or masked data (e.g., Group A vs. Group B not identified)
• Evaluates distributions, missingness, outliers, and data consistency
• Assesses overall event rates and variability without examining treatment effects
• Support of SAP finalization
• Confirms analysis populations (ITT, PP, safety) using blinded data
• Finalizes endpoint definitions, derivation algorithms, and censoring rules
• Confirms handling of missing data, intercurrent events, and protocol deviations
• Protocol deviation review
• Reviews and classifies deviations in a blinded manner
• Confirms rules for inclusion/exclusion prior to database lock
• Data readiness and database lock
• Verifies analysis datasets are complete and fit for purpose
• Confirms prespecified outputs and shells are appropriate
• Supports readiness for database lock without unblinding
• Maintenance of the blind
• Does not access unblinded treatment assignments or comparative results
• Avoids analyses that could indirectly reveal treatment effects
• Coordinates with independent/unblinded statisticians under strict firewalls, if applicable
• Documentation
• Documents all blinded decisions and rationale
• Ensures decisions are finalized and approved before unblinding

Key Distinction

• The project biostatistician remains fully blinded and supports trial integrity.
• Any unblinded interim or comparative analyses are handled by an independent DMC or unblinded statistician, not the project biostatistician.