Director, Clinical Data Scientist - Statistics
Core
Director-level clinical data science leader and people manager responsible for advancing clinical data science strategy, delivery excellence, and team capability to translate complex clinical data into actionable evidence for regulatory submissions and clinical development.
Role type
Director, Clinical Data Scientist (People Manager)
Builds
Submission-ready evidence packages, regulatory analysis outputs, and high-performing clinical data science teams
Domain
Pharmaceutical/Biotechnology Clinical Development & Regulatory Submissions
Deliverable
production ML models | dashboards & analysis
Required skills
Clinical trial design, Biostatistics, Longitudinal analysis, Survival methods, Causal reasoning, Simulation, Predictive modeling, Real-world data integration, Regulatory submission strategy, People management
Preferred skills
AI/ML-enabled methods, Automation, Cross-functional matrix leadership, Vendor oversight
Technologies
CDISC, FDA/EMA/PMDA/NMPA/MHRA regulatory frameworks
Responsibilities
Lead design and interpretation of quantitative analyses for regulatory submissions; Guide application of statistical and ML methods for patient-level prediction and risk assessment; Set clinical data science direction and delivery priorities; Provide scientific and operational oversight of internal teams and external partners; Identify and mitigate risks related to data quality and regulatory acceptability; Oversee resource planning and delivery execution; Provide people leadership including coaching, performance management, and talent development; Represent Clinical Data Science in cross-functional and regulatory forums; Drive continuous improvement in analytics practices through automation and standards.
Seniority
Director, People Manager