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
• Statistical modeling (MMRM, GLM, logistic models, Bayesian methods, longitudinal models)
• Exposure-efficacy and/or exposure-safety analyses
• SAP authorship and study design
• Simulation-based decision support
• Strong proficiency in R (required); Python or Stan experience a plus
• Familiarity with CDISC ADaM/SDTM preferred
• Excellent communication skills with the ability to present quantitative insights to cross-functional stakeholders
• Experience working closely with Statistical Data Scientists and Statistical Programmers.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.

We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.