Devon Humphreys Email & Phone Number

Austin, TX, US

Austin, TX

Southborough, Massachusetts, US

• Lead statistician on up to 6 concurrent studies to support New Drug Applications (NDA, US FDA) and New Drug Submissions (NDS, Health Canada)
• Strategic consultant under multiple FSP contracts to support development of protocols from the design stage through the analysis and CSR review
• Implemented advanced statistical methodology for complex trial designs, including adaptive designs with sample size re-estimation, propensity score matching and inverse probability of treatment weighting (IPTW), mixed.
• Developed study documents, including statistical sections of clinical protocols, statistical analysis plans (SAPs), table, listing, and figure (TLF) shells, Data Transfer Plans/Agreements (DTP/DTA), blinding and.
• Led biostatistics and programming efforts for CSRs, Data Safety Monitoring Committee (DSMC) meetings, Data Safety Update Reports (DSUR)/Annual Safety Reports, and Investigator's Brochures (IB)
• Reviewed ADaM datasets for quality and consistency with the SAP and shells and developed SAS and R programs to support programming activities and statistical review of data and TLFs

Austin, Texas, US

• Clinical Data Science team lead, mentoring and training junior biostatisticians and data managers
• Developed and executed statistical analysis plans (SAPs) for both clinical validation studies and analysis of real-world public health, behavioral, and epidemiological data from Everly Health’s vast database of user.
• Clinical Data Science lead on 8 major health analytics projects resulting in publication, EUA submission and approval, or supporting major company data infrastructure improvements
• Critically involved in building the Clinical Data Science team, including interviewing and hiring biostatisticians and data managers, and in writing all SOPs and Work Instructions for the team.
• Worked cross-functionally with the following teams to support both long- and short-term corporate goals: Commercial Analytics, Data Architecture, Product, Public Relations, Marketing, and Legal

Austin, Texas, US

• Developed clinical validation analysis plans for multiple at-home sample collection methods measuring various biomarkers, including cholesterol and lipids and HbA1c
• Trained newly-hired data management personnel on SQL, R, and data wrangling techniques
• Assisted with analyses and communications supporting 3 EUA submissions to the FDA for direct-to-consumer at-home sample collection kits for COVID-19 testing

Austin, TX, US

• Supported 510k and EUA submissions
• Authored and reviewed statistical analysis plans (SAPs) and data management plans (DMPs)
• Implemented CDISC/CDASH standards for data collection and SDTM reporting of clinical trials, including SDTM and ADaM validation using Pinnacle software
• Developed machine learning models in Python for complex clinical cases of bacterial vaginosis in a racially and ethnically diverse sample of women in the United States
• Developed dashboards and GUI sample size calculators for Study Managers to use to plan and track clinical trials in Python

Austin, TX, US

• Supported 510k submissions to the FDA
• Developed SAS programs and macros for the organization (SDTM, ADaM) and analysis of clinical trial data
• Implemented CDISC standards for data capture and reporting to regulatory agencies

Master'S Degree, Integrative Biology

Bachelor Of Science (B.S.), Genetics