Sriramu Kundoor is a seasoned SAS Certified Statistical Programmer with over 14 years of diverse experience in clinical research, pharmaceutical data analytics, and biostatistics. Currently serving as Associate Director of Statistical Programming at Organon LLC, Sriramu brings a proven track record of success across therapeutic areas such as women’s health, oncology, cell therapy, virology, obesity, diabetes, and rare diseases.
With hands-on expertise spanning Phase I–III clinical trials, Sriramu has contributed to multiple FDA regulatory submissions, including 2 NDAs, 2 BLAs, 1 sBLA (co-led), and 2 PMRs, and has played a critical role in ensuring compliance with CDISC standards, FDA regulations, and international regulatory requirements. His key contributions include the development and validation of SDTM and ADaM datasets, oversight of clinical data quality, and leading statistical programming teams through high-stakes submissions and deliverables. Throughout his career, Sriramu has held pivotal roles at leading organizations such as Organon Pharma Kite Pharma (a Gilead Company), Seattle Genetics, and Amylin Pharmaceuticals, where he managed programming activities for global regulatory submissions, developed reusable SAS macros, and led cross-functional collaboration across data management, medical writing, and biostatistics. He is well-versed in tools and platforms, including SAS (9.1–9.4), Enterprise Guide, SDD, LSAF, R, RStudio, and R Shiny, and is recognized for his ability to translate complex clinical data into regulatory-ready outputs with precision and compliance.
In addition to his technical accomplishments, Sriramu holds dual master’s degrees: an M.S. in Applied Statistics and Data Science from Kansas University Medical Center and an M.S. in General Chemistry from Texas A&M University. His early research in peptide-metal ion interactions and publications in peer-reviewed journals underscore his commitment to scientific rigor. Sriramu is also an accomplished conference speaker, having presented at industry forums such as PharmaSUG and WUSS, where he earned accolades for his innovative data solutions. With a blend of technical excellence, leadership, and domain knowledge, Sriramu Kundoor continues to be a driving force in advancing data-driven clinical development.