Major responsibilities include:

• Regulatory Real-World Evidence (RWE) & PMR Leadership
  • Led design and authorship of FDA-required studies, including a post-marketing requirement final report, NCO study protocols/SAPs, and algorithms validating 3-point MACE and CV mortality using Medicare–REGARDS linked data
  • Developed and led the clean-room gating framework with quantitative assessments of potential unmeasured confounding to support upcoming comparative safety work
  • Conducted multiple ad-hoc analyses integrating claims and biometric EHR data through multiple imputation and transportability methods, demonstrating negligible unmeasured confounding due to biometric covariates in upcoming claims-only safety study
  • Ran simulation studies evaluating bias from nondifferential outcome misclassification and applied validation-based adjustments to recover true effects
  • Authored several regulatory briefing documents and RTQ responses, ensuring methodological clarity and alignment with FDA expectations
• Additional Regulatory, Methodological, and Cross-Functional Contributions
  • Co-led protocol development for the Effectiveness NCO study, aligning core design elements with the Safety NCO study and adding two new negative control outcomes
  • Supported global regulatory needs through regulator-mandated safety analyses across U.S. and Japan datasets, identifying cross-regional methodological efficiencies
  • Contributed to Japan PMO/MOP work through study feasibility assessments and creation of an R Shiny app for automated power/sample size estimation across multiple testing frameworks
  • Authored key sections of two briefing documents for Japanese biopharma regulator, clarifying misclassification bias and differential attrition concerns in regulator-conducted studies
  • Coauthored two manuscripts on postoperative outcomes among women with osteoporosis and supported broader publication strategy with bone and publication teams
  • Evaluated PCORNet network performance to optimize site selection for future claims–EHR linked analyses
  • Served as a reviewer for Amgen’s internal protocol governance body

Responsibilities included:

• Designing pharmacoepidemiological hepatology, dermatology, and oncology studies with claims and electronic health record data, including studies that integrate both types of data
• Implementing advanced causal inference methods to surmount common problems in pharmacoepidemiological analyses
  • Clone censor weight approach to address immortal time bias due to the start of follow-up and treatment initiation not coinciding
  • Inverse probability of censoring weight approach for informative right censoring
  • Prevalent new user design for non-contemporaneous marketing in comparative effectiveness studies
• Writing proposals and developing presentations to help Target RWE win new contracts and continue existing ones

• Completed doctoral epidemiology training and dissertation on nicotine vaping’s unintended consequences
• Performed teaching assistant duties for numerous epidemiology and statistics courses