Senior Manager/Associate Director, Biostatistics

Rapport Therapeutics seeks a Senior Manager or Associate Director of Biostatistics to lead statistical design, analysis, and interpretation of clinical trial data for neuromedicine programs. The role involves hands-on oversight of study protocols, regulatory submissions, and cross-functional collaboration in a remote position.

Responsibilities

• Oversee protocol development, statistical analysis plans, and clinical study reports for regulatory submissions
• Provide strategic statistical leadership on study design, endpoints, sample size calculations, and statistical methods
• Manage statistical programming workflows including SDTM/ADaM datasets, tables, listings, and figures
• Validate statistical analyses and interpret results for clinical reports, regulatory documents, and publications
• Oversee external CROs and vendors; participate as biometrics representative on cross-functional teams

Requirements

• PhD with 3+ years biostatistics experience (Senior Manager) or PhD with 6+ years (Associate Director)
• MS with 6+ years biostatistics experience (Senior Manager) or MS with 9+ years (Associate Director)
• Proficiency in SAS or R for statistical analysis and data programming
• Experience with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA)
• CNS drug development experience and expertise in survival analysis or adaptive design highly desirable