Clinical Trials: Preclinical & Phase I-IV
* Preparing Statistical Analysis Plans (SAP) – considering adaptive design.
* Statistical representation and presentation to regulatory authorities in USA & Europe (FDA, EMEA).
* Modeling and simulation of clinical data, and exploratory analysis of preclinical data.
* Data and Safety Monitoring Board (DSMB) interim analysis planning and statistical support.
* Support in implementation of Critical Path Opportunities for Medical devices & Pharmaceuticals.
* Statistical reports and analysis interpretation.
Statistical programming using: SAS, East, StatXact, WinNonlin, Winbugs, Spotfire.
Biostatistical research
* Grant proposal writing.
* Study design & power calculations to determine sample size.
* Statistical analysis of surveys (such as NHIS, NHAENES, CENSUS 2000, NHCS, and others.) or study data.
Statistical programming using: SAS, S-PLUS, STATA, R, SUDAAN.