Senior Biostatistician & RWE Scientist
Eight-plus years delivering federally funded observational research, vaccine effectiveness studies, and continuous post-market surveillance analytics on accumulating clinical and claims data. My statistical programming background spans Phase 2/3 clinical trial support at an NIH-funded Vaccine and Treatment Evaluation Unit, alongside four years leading exploratory and interim analyses of large-scale, continuously monitored real-world cohorts as a CDC contractor. I am an R-primary programmer with strong SAS proficiency.
- 8+
- years in RWE and infectious disease data analysis
- 5M+
- patient records monitored on a rolling basis
- 35%
- reduction in data discrepancies from automated QA scripts
- 2
- first- and co-authored peer-reviewed publications
Core expertise
- Continuous safety and effectiveness monitoring. Evaluating predefined surveillance criteria on a rolling basis across ongoing, multi-year cohort studies to flag emerging trends and signals.
- Clinical trial statistical programming. CDISC-compliant SDTM/ADaM dataset development, DSMB tables, listings, and figures, and interim safety analyses under ICH-GCP and FDA regulatory standards.
- Survival and time-to-event modeling. Cox proportional hazards and time-dependent exposure analysis, methodology directly transferable to interim safety and efficacy monitoring.
- Cross-functional translation. Turning statistical findings into clear, actionable summaries for non-technical federal stakeholders.
Experience
- Serve as primary analytic support monitoring accumulating vaccine effectiveness and safety data across ongoing, multi-year nursing home cohort studies (5M+ patient records), evaluating predefined surveillance criteria on a rolling basis.
- Conduct interim and exploratory analyses on continuously updated claims (MarketScan, CMS inpatient files) and multi-platform EHR data (Truveta, PointClickCare, Epic, Cerner).
- Program all statistical analyses independently in R and SAS, including survival analysis, propensity score matching, and longitudinal cohort modeling, producing reproducible, audit-ready code.
- Author regulatory-facing RWE deliverables, including a first-author JAMDA (2024) manuscript evaluating diagnostic criteria against a gold-standard confirmatory endpoint, and a co-authored Vaccine (2024) publication using Cox proportional hazards modeling and time-dependent exposure analysis.
- Supported Phase 2/3 clinical trial conduct for the Pfizer-BioNTech COVID-19 vaccine trial at one of ten national NIH-funded VTEU sites, developing CDISC-compliant SDTM datasets and analysis files under ICH-GCP and FDA regulatory standards.
- Generated tables, listings, and figures (TLFs) for Data Safety Monitoring Board (DSMB) meetings and interim safety analyses.
- Programmed R and SAS scripts for automated data quality monitoring of accumulating trial data, reducing data discrepancies by 35% and accelerating database lock for regulatory deliverables.
- Conducted real-world evidence analyses bridging randomized trial data with the Georgia immunization registry (GRITS) to connect trial-phase findings to real-world post-approval outcomes.
Managed high-volume, continuously accumulating surveillance data (150+ weekly cases), performing real-time statistical analysis and automated reporting to identify emerging outbreak trends for state and federal decision-makers.
Conducted retrospective observational analysis of 2,000+ Hepatitis C virus-positive patients using EHR data, programming statistical analyses in SAS and presenting findings at the Florida College of Emergency Physicians Annual Conference (2019).
Conducted pharmaceutical R&D on antimicrobial drug-loaded matrices, applying drug development principles from formulation through efficacy testing, and completed a pharmaceutical manufacturing rotation across quality control and production under cGMP frameworks.
Methods & standards
Reduced data discrepancies by 35% and accelerated database lock for regulatory deliverables through automated QA scripting.
Read the publications