Michael Rimler
Vaccines Area Head, Flu Covid at Gsk
Based in Cincinnati, United States
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Seniority
Other
Department
Other
Location
Cincinnati
Industry
Pharmaceutical Manufacturing
Company size
10001+
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m•••••••@gsk.com
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Background
About Michael Rimler
Current Interests:• Application of open source technologies in clinical research • Application Data Science methodologies in clinical research• Technical innovations to improve the efficiency of delivering the clinical data pipeline• Modernization of the Traditional Statistical Programmer role in the pharmaceutical industry• Integrating R into the toolbox of Biometrics teams reporting results of Clinical Trial protocols and submitting applications for regulatory reviewIndustry Skills:• 15+ years in the biometrics field leading global and cross-functional teams in the pharmaceutical industry• SAS, R (tidyverse), R Markdown, and a wee bit of python and shiny programming skills • Design thinking, innovation, agile methodologies (Kanban, scrum, sprints)• CDISC, SDTM, ADaM, all trial phases, simple and complex study designs, ISS, ISE, DSUR, PBRER, first-time-in-human (FTIH), meta-analyses • Indications include Influenza, COVID-19, HIV, immunology, rheumatoid arthritis, myasthenia gravis, COPD, asthma, Type 2 diabetes mellitus (T2DM), diabetic neuropathy, and hyperlipidemia• Extensive engagement in Phase I trials and non-compartmental pharmacokinetic analyses, including PK parameter derivation, bioequivalence testing, steady-state assessment, and dose proportionality testing
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