Principal Biostatistician
Core
Lead biostatistical analyses for clinical trials and real-world evidence applications, applying causal inference and machine learning to support regulatory submissions and clinical decision-making.
Role type
Principal Biostatistician (Clinical Trials & Real-World Evidence)
Builds
Clinical study reports, regulatory documents (PMA, CE Mark), and data-driven solutions for clinical teams.
Domain
Pharmaceutical/Medical Device industry, Clinical Research, Real-World Evidence (RWE)
Deliverable
production ML models
Required skills
Causal inference methodologies, Machine learning, Python, R, SAS, Survival analysis, Clinical trial design, Statistical modeling, Regulatory guidelines (GCP, ICH, FDA, ISO)
Preferred skills
AI agent development, Machine learning dashboards, Real-world evidence (RWE) expertise, Change management
Technologies
Python, R, SAS, MS Office Suite
Responsibilities
Lead statistical analysis for multiple clinical trials and coordinate study reports; Collaborate on new product development and regulatory submissions; Represent Biostatistics on project teams and communicate status; Research and recommend novel statistical methodologies; Provide guidance on ad hoc data analysis and publications; Compile technical documents for audits; Contribute to standardization of Biostatistics processes and SOPs; Lead data analysis for data monitoring committees; Mentor junior statisticians.
Seniority
Principal, hands-on IC with mentorship