Senior Statistician, Center for Vaccine Innovation and Access
Core
Senior biostatistician leading statistical design, analysis, and reporting for Phase 1-3 oral polio vaccine clinical trials.
Role type
Senior IC clinical biostatistician
Builds
Clinical study reports, manuscripts, and regulatory submissions for novel oral polio vaccines
Domain
Global health / Vaccine development / Clinical trials
Required skills
Biostatistics, Clinical trial methodology, SAS, R, Sample size/power calculations, Data and Safety Monitoring Board (DSMB) support, Regulatory submission support, Scientific communication
Preferred skills
Vaccine clinical trial experience, Polio or enteric vaccine studies experience
Technologies
SAS, R
Responsibilities
Lead statistical design of OPV/nOPV trials including randomization and interim analyses; Develop and review statistical analysis plans; Analyze trial data for immunogenicity, shedding, and safety endpoints; Provide technical oversight of statistical CRO activities; Contribute to protocol design and regulatory submissions; Present statistical material at scientific meetings
Seniority
Senior, hands-on IC