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  • Safety Statistician - ASAP Process Focus


    30 years of experience 1 project USA Research & Development
    Aggregate safety assessment planningOngoing aggregate safety evaluation BiometricsSafety & Pharmacovigilance BiostatisticsData scienceData visualizationDrug SafetySafety AnalyticsSignal Detection
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    ·         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…