Director, Quantitative Lead

Position Summary:

Praxis is hiring a Director, Quantitative Lead to guide the statistical design, quantitative decision-making, and modeling across our clinical development programs. This senior role blends biostatistics, exposure-efficacy/safety modeling, exploratory analyses and quantitative strategy within a modern, metadata-driven analytical environment.

You'll partner closely with Statistical Data Scientists, Statistical Programmers, Clinical Development, and Clinical Pharmacology to ensure that all quantitative outputs from exploratory modeling to SAP-driven analyses are scientifically rigorous, reproducible, and aligned with program objectives. This is both a strategic and hands-on scientific role, ideal for a senior quantitative leader who enjoys both methodology and applied modeling.

Primary Responsibilities:

• Lead statistical design for clinical studies, including estimands, endpoint selection, sample size, and modeling approaches
• Author or oversee SAPs and associated analysis specifications
• Guide quantitative strategy across exploratory, interim, and confirmatory study phases
• Lead exposure-efficacy and exposure-safety analyses using clinical exposure metrics
• Apply statistical modeling approaches in R or Python
• Develop simulation-based scenarios to support dose selection and benefit-risk assessments
• Oversee blinded exploratory analyses using ARR and other metadata-driven layers
• Guide Statistical Data Scientists in the implementation, visualization, and reproducible execution of exploratory models
• Ensure quantitative analyses are implemented within reproducible, metadata-driven frameworks
• Partner with Statistical Data Scientists and programming teams to translate quantitative intent into executable specifications
• Support validation, traceability, and audit readiness of all quantitative workflows
• Provide quantitative interpretation for study teams, governance discussions, and regulatory documents
• Review CSRs and contribute to regulatory responses involving quantitative rationale
• Mentor Statistical Data Scientists and Statistical Programmers on modeling, statistical methodology and interpretation.

Qualifications and Key Success Factors:

• PhD or Master’s in Biostatistics, Statistics, Data Science, Applied Mathematics, or related quantitative discipline
• 8-12+ years of quantitative experience in clinical development