Experts
1 Expert
Safety Statistician - ASAP Process Focus
GBall
30 years of experience 1 project USA Research & DevelopmentAggregate safety assessment planningOngoing aggregate safety evaluation BiometricsSafety & Pharmacovigilance BiostatisticsData scienceData visualizationDrug SafetySafety AnalyticsSignal DetectionShow more skills.
· Thirty-six years of strong leadership, managing people and projects; 22 years as a Biostatistician, familiar with all phases of development, submissions, and interactions with regulatory authorities (therapeutic areas: vaccines, CV, diabetes, oncology, and others)
Past 5 Years:
· Created a Safety Statistics group embedded in the Global Vaccine Safety organization
· Co-leading the PhUSE Safety Analytics working group (with…