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FOUNDER PROFILE ;CEO Profile

Vijay Chauhan, Ph.D.
Senior Director (Biostatistics)

 

EDUCATION

 

1982-1985

Ph.D.(Statistics) - Mixed Model Methods. Edinburgh University, Scotland

1986-1987

Postdoctoral Fellow - Statistical modeling using mixed models. Swiss Federal Institute of Technology, Zurich, Switzerland

1989-1990

Postdoctoral Fellow - Estimation of variance components. McGill University, Montreal, Canada

BIOSTATISTICS & SAS EXPERIENCE

 

PhD in Statistics with specialization in mixed models methodology for prediction of fixed and random effects, and in estimating variance components. Over 25 years of statistical experience including 13 years in the pharmaceutical and biotech companies and CROs.

Responsibilities in my various assignments in the pharmaceutical industry included protocol development, writing Statistical Analysis Plans and programming specifications, supporting IDMC, DSMB and drug development advisory boards in evaluation and interpretation of clinical trial results and formulating recommendations, integrated summary of efficacy and safety, CRFs review, contributing to writing of clinical study reports and pre-NDA briefing packages, direct interactions with FDA reviewers and responding to FDA queries, assisting Regulatory Affairs in drafting letters of responses to FDA. I have worked closely with Clinicians and marketing groups for publication of clinical trials results. I have been a co-author in research publications of clinical trials results.

Therapeutic areas on my experiences include cardiovascular, hypertension, diabetes, oncology, Mesothelioma trials, Dermatology (Acne Vulgaris), CNS (Bipolar I Disorder and Schizophrenia), weight loss, anti-fungal, pain studies, diagnostic imaging, anti-infective (complicated skin structure infections, complicated intra-abdominal infection), postmenopausal management and contraceptive studies.