Karthik Akinapelli is a seasoned Lead Statistical Programmer with over 10 years of experience in the pharmaceutical industry. Currently serving as an Associate Director at Takeda Pharmaceuticals, he specializes in clinical trial data analysis and regulatory submissions to FDA and EMA.
Throughout his career at companies including PTC Therapeutics, Iterum Therapeutics, and Durata Therapeutics, Karthik has successfully led multiple Phase III projects and managed cross-functional teams in developing critical statistical analyses. He has particular expertise in infectious disease therapeutics and has made significant contributions to celiac disease research.
Karthik holds a Master's in Biostatistics from the University of Florida with a 3.92 GPA, a Master's in Chemistry from Texas A&M University Commerce, and a Bachelor's in Pharmacy from Kakatiya University in India. He has co-authored multiple publications focused on bacterial skin infections and their treatments, and has presented his research at several symposiums, including winning third prize at the North Texas Life Science Research Symposium.
His technical expertise includes advanced proficiency in SAS programming tools and sample size software, combined with a deep understanding of CDISC standards and clinical data management. Karthik's work has contributed to successful FDA and EMA submissions, Advisory Committee meetings, and numerous publications in the field of pharmaceutical research.