Divakar Sharma, Ph.D., is Vice President, Biometrics at Hurley Consulting. He is a biostatistics professional with over 25 years’ experience in all phases of drug development. Dr. Sharma has both domestic and international experience in many therapeutic areas including ADHD, AIDS, anti-infectives, biosurgery (devices and cell therapies), cardiology, gastrointestinal, genetic diseases, hematology, oncology, ophthalmics, neuroscience, and organ transplant.
At Hurley Consulting Dr. Sharma is responsible for the design and conduct of statistical analyses. He assures that timely and high quality analyses are conducted, utilizing appropriate statistical techniques, in accordance with the protocol, the statistical analysis plan, health authority guidelines, and Good Clinical Practice. He oversees the preparation and validation of CDISC compliant datasets. He also evaluates and supervises the design of electronic data capture databases created by third parties for data entry. In addition, he is responsible for the statistical interpretation of data analyses, and in conjunction with the person responsible for the scientific and/or clinical interpretation of the data, he determines the final data interpretation. He is responsible for providing the results of statistical analyses to Scientific Affairs and the Vice President, Regulatory Affairs, and for supporting the creation of nonclinical and clinical reports and summary documents.
Before joining Hurley Consulting, Dr. Sharma worked for two years as an independent consultant, providing strategic global biometric drug development services in biotech and pharmaceutics in all therapeutic areas. He has also worked at Cubist Pharmaceuticals, Shire Pharmaceuticals, Genzyme, and Aventis. Dr. Sharma began his career at Merck as a biostatistics consultant and progressed to Associate Director, Clinical Biostatistics, Analysis and Research Data Systems (CBARDS) MRL. During his ten years at Merck he led and assisted filing activities in several therapeutic areas (cardiovascular, AIDS, ophthalmic, neuroscience, and gastrointestinal) and provided biometrics support for mega-trials with emphasis on data safety monitoring boards and steering committees.
Dr. Sharma holds a bachelor’s degree in statistics/mathematics from the University of Delhi and both master’s and doctoral degrees in statistics from the University of Florida. He is a member of the American Statistical Association, the International Biometrics Society, and the Eastern North American Region (ENAR).