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.