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 claims records analyzed
- 31,136
- residents in first-author diagnostic validation cohort
- 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.
- Correlated and longitudinal data. Generalized estimating equations for repeated measures within facilities, time-varying exposures, and validation of competing analytic definitions before choosing one.
- 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, evaluating predefined surveillance criteria on a rolling basis.
- Rebuilt a nursing home Infection Preventionist time-use analysis from the ground up after identifying records assigned to the wrong calendar quarters; fit GEE models with compound symmetry correlation and compared four quarter-assignment methods before recommending one.
- 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, GEE, 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.
- Developed case report forms, edit checks, and data validation rules, and programmed R and SAS scripts for automated quality monitoring of accumulating trial data.
- 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 nanofibrous matrices for chronic wound infections, including drug release, dissolution, and antimicrobial activity assays, and completed a pharmaceutical manufacturing rotation across quality control and production under cGMP frameworks.
Methods & standards
Found a structural flaw in an inherited analysis, rebuilt it end to end, and validated four competing definitions before recommending one.
Read the publications