Senior Manager/Associate Director, Biostatistics
Rapport Therapeutics
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
Vacancy posted 28 days ago
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