Provide strategic consulting, study design, oversight and/or execution of analysis, and peer-reviewed publication for health care research to support medical device, diagnostic, and pharmaceutical sponsors, as well as academic and clinical researchers. Studies include prospective, retrospective, and prospective/retrospective hybrid studies, pragmatic and chart review studies, registry and claims database studies. Provide guidance to clients on data sources and methods of data capture, study designs and statistical methodology that align with both the data and study objectives, and publication strategy for results. Provide scientific leadership for RWE research team and work closely with business development team. Develop training for RWE researchers, lead adoption of new methods and processes, and provide mentoring for team members.

Provided study design, data evaluation, and statistical support for a wide variety of health outcomes, healthcare utilization and economic studies. Led programmers in creating analyzable datasets from large-scale payor, hospital and EHR datasets. Performed feasibility analyses and descriptive or predictive modeling. Presented study results at professional conferences and published in peer-reviewed medical and economic journals.

Served as study statistician for medical devices, pharmaceuticals, and diagnostics. Responsible for sample size calculation, statistical analysis plans, interim analysis plans, program requirements documents, and statistical sections of clinical study reports. Represented sponsors in negotiations and presentation of study results to FDA.