Clinical Trials: Preclinical & Phase I-IV

* Lead statistician for filing of 14 NDA (New Drug Application) /BLA (Biologic License Application) submissions in USA, Europe, and Japan.

* Twenty Five years of experience in pre-clinical and phase I-IV clinical trials of drugs and medical devices.

* Held Senior Management position in Biostatistics at leading pharmaceutical, biotech and CRO companies, for a total of 25 years.

* Senior statistical advisor to members of the Nobel Prize committee of Medicine and Physiology for eight years.

*Expertise in all standard statistical methods used in drug development, plus design of experiment, adaptive methods, Bootstrap & Jackknife resampling, modeling & simulation, negative binomial regression, crossover, Bayesian, survey sampling.

* Over 80 publications including articles, book chapters and presentations in biostatistics sphere.

Biostatistics therapeutic specialization in:
• Central Nervous System (anti-psychotics, anti-depressives, stroke and Alzheimer's disease)
• Oncology (Breast Cancer, Cervical Cancer, Leukemia, Hodgkin's Disease, Prostate, Sarcoma,
Non-small Cell Lung Cancer)
• Infectious Diseases (Anti-Bacterial and HIV/AIDS, CMV, HSV, HCV)
• Local Anesthetics and Analgesics
• Cardiology
• Urology
• Rheumatoid Arthritis
• Neurology
• Psoriasis

* Ph.D. Statistics

Biostatistical research

* Fifteen years of experience as Senior Statistician for various organizations.

* Expertise in Study design, Survey sampling, Regression modeling, Analysis of Survival data, Statistical Qualtity Control, Design of Experiments & ANOVA, Multivariate Analysis, Time Series & Forecasting.

* Analysis of surveys including NHIS, NHAENES, CENSUS 2000, NHCS, SEER, A.C.S., MEPS.

* Experience assisting researchers with study design (sampling, power calculations, etc..), or with data analysis (weighting, hypothesis testing, regression analysis, etc..).

* Taught univeristy courses covering descriptive statistics, probability theory, parametric and non-parametric statistics, correlation, regression and time-series analysis.

* Ph.D. Statistics

Statistical programming using: SAS, S-PLUS, STATA, R, SUDAAN.