Srinivasa Mukkala| Unloved Child| VP of Operations, Biostatistics and Programming| Epis Data

Leadership in Biostatistics: Driving FDA Approvals in Gene Therapy and Clinical ResearchIn this episode, we speak with Srinivasa Reddy Mukkala, Vice President of Operations – Biostatistics and Statistical Programming at EPIS DATA, about the critical role of statistical leadership in regulatory success.Srinivasa has contributed to multiple FDA approvals, including breakthrough gene therapies such as ZYNTEGLO for Beta-Thalassemia and LYFGENIA for Sickle Cell Disease. He also served as statistical programming lead for NUZYRA, an FDA-approved tetracycline-class antibiotic.We explore:The role of biostatistics and statistical programming in FDA submissionsDelivering regulatory-ready clinical trial dataThe complexity of gene therapy trialsLeadership in biometrics and global operationsCareer progression from pharmacist to data science executiveThe future of clinical research, regulatory science, and data integrityThis conversation is essential listening for professionals in biostatistics, statistical programming, clinical data management, regulatory affairs, pharmaceutical development, and life sciences leadership.If you are involved in clinical trials, gene therapy, FDA submissions, or biometrics strategy, this episode offers practical insights from someone who has helped bring transformative therapies to patients worldwide.Subscribe for more conversations with leaders shaping the future of biostatistics, clinical research, and pharmaceutical innovation.