Aloka Chakravarty Email Address

Acting Director, Office of Biostatistics

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation. The FDA also provides accurate, science-based health information to the public.

Seasoned executive with 30 years’ leadership experience in Biostatistics, Epidemiology and Data Sciences including Artificial Intelligence/Machine Learning. My expertise is in building high-velocity multidisciplinary teams with expertise in quantitative design, analysis, interpretation to deliver cross-cutting implementation of data-driven decisions. With a blend of IQ and EQ, aspects that differentiate me as a leader: •Domain expertise in 6 sectors: Drugs, Therapeutic Biologics, Vaccines, Devices, Digital Technologies, Foods •Track record of building and managing cross-functional teams of 262 PhD level scientists •Inaugural Director of Data Analytics in the Office of the Commissioner leading RWD activities in COVID-19 evaluation and driving data innovation across all 7 Centers of the FDA •Founding Director of 3 Biostatistics divisions supporting Biologic Therapeutics, Oncology & Hematology and Quantitative Drug and building quantitative roadmap •Expert knowledge spanning 28 years of drug development and evaluation, methodologies in randomized clinical trials (RCT) and evidence generation using Real World Data (RWD) •In-depth knowledge across all 17 therapeutic areas in drugs - signatory of 1000+ NDA and 8000+ IND regulatory submissions •International thought leadership in policy and guidance development: Statistical Lead on ICH guidance on Multi-Regional Clinical Trials (MRCTs) with 48 countries •Experience in collaboration with professional organizations such as DIA, ASCO, ASA, SCT and with managing private-public partnerships such as Reagan-Udall Foundation for FDA and Critical Path Institute •Author / Keynote speaker: 30+ peer-reviewed publications, 5 book chapters and 250+ presentations •Board Member/Advisor at GMU, UMBC and Temple U. Teaching faculty at NIH and FDA •Elected Fellow of American Statistical Association •Associate Editor, Statistics in Biopharmaceutical Research SPECIALTY: Real World Data (RWD) | Real World Evidence (RWE) | Data Sciences | Pharmaco-Epidemiology | Drug Development Tools (DDT) | Artificial Intelligence | Machine Learning | Precision Medicine | Surrogate Markers | Biomarkers including Digital Biomarkers | Meta-Analysis | Quantitative Drug Safety | Data Fitness-of-Use | Data Characterizations | Social Media Data | Data Mining | Social Determinants of Health (SDoH) | Regulatory Guidance, Compliance and Policy Development | Electronic Health Records | Claims | Registries |