Principal Scientist, Biostatistics, Clinical Safety Statistics
Core
Lead statistical analysis and safety evaluation for vaccine and infectious disease clinical trials and post-marketing data to inform benefit-risk profiles.
Role type
Principal Scientist, Biostatistics (Clinical Safety)
Builds
Aggregate safety evaluation strategies and analysis for drug and vaccine programs
Domain
Biopharmaceuticals / Clinical Safety Statistics
Deliverable
production ML models | dashboards & analysis
Required skills
Biostatistics, Clinical Risk Management, Clinical Study Design, Clinical Trials Analysis, Statistical Software (SAS/R), Regulatory Knowledge, Project Management, Strategic Planning
Preferred skills
Drug/Vaccine Development Lifecycle Knowledge, AI Tools in Drug Development
Technologies
SAS, R
Responsibilities
Serve as therapeutic area lead for vaccine and infectious disease projects; Provide statistical leadership for compound safety evaluation strategy; Design innovative statistical methods for safety evaluation; Partner with cross-functional teams to execute aggregate safety evaluation; Ensure safety deliverables meet regulatory guidance; Develop processes and tools for safety evaluation
Seniority
Principal, strategic leadership & hands-on analysis