Michael Rimler

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

Experience

1. Open Source Technologies Director

   Phuse

   Apr 2023 — Present · Cincinnati, OH, US

   The Open-Source Technology Director drives and promotes activities related to the use of open-source technology in life sciences as they relate to fulfilling the PHUSE Mission.

Education

• University of Michigan

  Doctor of Philosophy (PhD), Economics

  2000 — 2006

• University of Michigan

  Master of Arts (MA), Economics

  1998 — 2000

• The University of Alabama

  Bachelor of Science (BS), Economics

  1994 — 1998

Skills

• Statistical Software
• Sas
• CRO Management
• Edc
• Statistical Data Analysis
• Data Management
• Pharmaceutical Industry
• Fda
• Data Validation
• Anova
• Statistical Modeling
• Clinical Trials
• Statistical Programming
• Multivariate Statistics
• Medical Writing
• Programming
• Analytics
• Data Mining
• Quantitative Research
• Validation
• Statistical Reporting
• Cdisc Standards
• Sas Programming
• Cdisc
• Research
• Statistical Consulting
• Forecasting
• Clinical Research
• Oncology
• Sas Base
• Protocol
• Latex
• 21 Cfr Part 11
• Clinical Data Management
• Gcp
• Sas Certified Base Programmer
• CRO
• Good Clinical Practice (Gcp)
• Econometrics
• Analysis