Principal Scientist, Biostatistics, Clinical Safety Statistics
Core
Lead safety monitoring and evaluation for Oncology Therapeutic Area programs, developing strategic statistical plans and conducting analyses of safety data from clinical trials and post-marketing sources to inform product safety profiles and benefit-risk assessments.
Role type
Principal Scientist, Biostatistics (Clinical Safety)
Builds
Aggregate safety evaluations and benefit-risk assessments for oncology drug and vaccine development programs
Domain
Biopharmaceuticals / Oncology / Clinical Safety Statistics
Required skills
Survival analysis, Meta-analysis, Bayesian methods, Propensity score analysis, SAS, R, Clinical trial design, Regulatory safety reporting
Preferred skills
Drug development lifecycle knowledge, Novel statistical method development, AI tools in drug development, Disease biology
Technologies
SAS, R
Responsibilities
Lead compound safety evaluation strategies and analyses for oncology projects; Partner with Clinical Safety Risk Management and other functions to plan aggregate safety evaluations; Ensure safety deliverables meet regulatory guidance and SOPs; Develop processes and statistical tools for safety evaluation; Communicate safety analysis results to cross-functional teams, management, and regulators.
Seniority
Principal, hands-on IC with strategic leadership
