
Director, Quantitative Lead
Praxis
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $178,000 - $198,000 per year
Job Level
Senior
Tech Stack
Python
About the role
- 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.
Requirements
- 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.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits.
- Dollar-for-dollar match up to 6% on eligible 401(k) contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Flexible wellness benefit.
- Generous PTO, paid holidays and company-wide shutdowns.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical designestimandsendpoint selectionsample sizestatistical modelingMMRMGLMlogistic modelsBayesian methodslongitudinal models
Soft skills
excellent communication skillsmentoringcollaborationquantitative interpretation
Certifications
PhDMaster’s in BiostatisticsMaster’s in StatisticsMaster’s in Data ScienceMaster’s in Applied Mathematics