Ge Guo Email & Phone Number

Switzerland 🇨🇭 , Ch

New York, Ny, Us

ObvioHealth is a VROTM(Virtual Research Organization) that brings health-related research into the everyday lives of real people. The app allows for remote studies that make it easier for people to participate in research and delivers better data reflecting real behaviors.• Lead Biostatistician on clinical studies conducted by a thriving startup specializing in theexecution of real-world evidence studies through a revolutionary digital clinical trialmanagement platform (ClaimIt).• Developed statistical strategies for study design; authored Statistical Analysis Plan (SAP);performed statistical analysis and execute Statistical Analysis Report (SAR) of Tables,Listings and Figures (TLFs) using R programming; provided interpretations of analysisresults for the Clinical Study Report (CSR) development.• Supported the data management function in the electronic Case Report Form (eCRF)development during the study setup phase, and in data monitoring and cleaning duringthe study execution and closeout phases.• Provided conceptualization and direction for the digital development of the TLFsautomation process within ObvioHealth’s proprietary clinical trial platform (ClaimIt).• Provided consultation to Project Managers, Data Management, Scientific Affairs, andsenior leadership on all matters related to biostatistics.• Participated in a variety of business development activities including proposaldevelopment, client meetings/presentations.

Switzerland 🇨🇭 , Ch

• Lead Biostatistician on clinical trial studies, including Real World Evidence, Infectious Diseases, Point of Care, Cardiac, Women’s Health, Oncology, Reference Range, Sample Stability, Assay Performance, and Urinalysis studies on evaluating the analytical validity and clinical utility of the In Vitro Diagnostics (IVDs) products• Author Statistical Analysis Plan (SAP); program Analytical Dataset (ADS) by extracting and merging data from clinical and technical Electronic Data Capture (EDC) systems; execute Statistical Analysis Report (SAR) of tables, figures and listings using SAS and R programming for regulatory submissions use; provide statistical input to address regulatory questions for study submissions; support on other statistical activities including post hoc analysis and analysis for publications use • Support data management team in the electronic Case Report Form (eCRF) development during the study setup phase, and in data cleaning during the study closeout phase • Improve the process of data management, including database monitoring and data cleaning, through authoring Data Integrity Check Guidance Document and applying it on clinical trial studies• Represent the team to participate in cross-functional initiatives regarding Real Work Evidence; represent Roche Diagnostics Biostatistic team as an organizer in conferences including the FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference, the MidWest SAS Users Group, and the MidWest BioPharmaceutical Statistics Workshop

Switzerland 🇨🇭 , Ch

• Lead Biostatistician on clinical trial studies, including Real World Evidence, Infectious Diseases, Point of Care, Cardiac, Women’s Health, Oncology, Reference Range, Sample Stability, Assay Performance, and Urinalysis studies on evaluating the analytical validity and clinical utility of the In Vitro Diagnostics (IVDs) products• Author Statistical Analysis Plan (SAP); program Analytical Dataset (ADS) by extracting and merging data from clinical and technical Electronic Data Capture (EDC) systems; execute Statistical Analysis Report (SAR) of tables, figures and listings using SAS and R programming for regulatory submissions use; provide statistical input to address regulatory questions for study submissions; support on other statistical activities including post hoc analysis and analysis for publications use

Switzerland 🇨🇭 , Ch

• Biostatistics - Contributed and reviewed Statistical Analysis Plan (SAP)- Authored Analytical Dataset (ADS) specification documents- Extracted and merged data from the clinical and technical Electronic Data Capture (EDC) systems in creating Analytical Dataset (ADS) using SAS - Generated data monitoring reports for study monitoring and data verification using SAS • Data Management - Contributed and reviewed Data Management Plan- Supported Data Managers in electronic Case Report Forms (eCRFs) database setup, testing, modification, verification and validation using SAS and Electronic Data Capture (EDC) systems

• Biostatistics and SAS Programming - Reviewed Study Protocols and Statistical Analysis Plans (SAP)- Provided statistical consulting in understanding biostatistics-related requirements for data quality and analysis • Data Management - Created and implemented edit checks on the resulting SAS data exports generated by Electronic Data Capture (EDC) system- Supported electronic Case Report Form (eCRF) database setup, testing, modification, verification and validation on Electronic Data Capture (EDC) system • Data Visualization - Lead website and dashboards design and development, representing Key Performance Indicators (KPI) data generated by all functional areas at West Virginia University Clinical & Pharmacologic Research Center

• Biostatistics and SAS Programming - Reviewed Study Protocols and Statistical Analysis Plans (SAP)- Provided statistical consulting in understanding biostatistics-related requirements for data quality and analysis • Data Management - Created and implemented edit checks on the resulting SAS data exports generated by Electronic Data Capture (EDC) system- Supported electronic Case Report Form (eCRF) database setup, testing, modification, verification and validation on Electronic Data Capture (EDC) system • Data Visualization - Lead website and dashboards design and development, representing Key Performance Indicators (KPI) data generated by all functional areas at West Virginia University Clinical & Pharmacologic Research Center

Morgantown, West Virginia, Us

• Assigned to biomedical research based on diseased animal models such as diabetic rat model and stroke rat model• Served as a hands-on clinical researcher performing animal surgery, microvessel isolation, microvessel cannulation• Provided accurate data processing including data collection, data analysis, and data management for weekly reports and presentations• Awarded second place presenter at the Annual Van Liere Research Convocation for excellence in research finding, poster design, and presentation skills• Assisted with modifying protocol and experiment design based on period summary of each project

Morgantown, West Virginia, Us

• Skilled at animal surgery and molecular biology assays, including DNA isolation, protein extraction and quantification, DNA isolation, Western blot, RNA isolation, and PCR amplification• Experienced in handling laboratory animals, including wild type mice and gene-knockout mice.• Provided accurate data analysis and data presentation of five projects

Master Of Science (Ms), Statistics

Master Of Science (Ms), Exercise Physiology