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 30 years of statistical experience including 20 years in the pharmaceutical and biotech companies and overseeing CROs. Provide services mainly to J&J, Celgene, and Bayer Healthcare. Major companies Have trained Biostatisticians and SAS Statistical Programmers earning big in the pharmaceutical industry. Interviewed over 150 candidate for positions of Statistical Programmers and Biostatisticians.

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 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. Worked closely with Clinicians, Data management, Regulatory, and Marketing groups for publication of clinical trials results. Have been a co-author in many research publications of clinical trials results.

Therapeutic areas on experiences include oncology, cardiovascular, hypertension, diabetes, 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. Recent experience in over 25 Phase-1 oncology studies involving complex design and analysis of PK parameters.