Srinivas Maddela is a Senior SAS Programmer and Clinical Data Analytics professional with over 12 years of experience supporting Phase I–IV clinical trials across oncology and other therapeutic areas. Based in Austin, Texas, he specializes in end-to-end clinical data programming for regulatory submissions, with deep expertise in CDISC standards, including SDTM, ADaM, and define.xml development. Srinivas has extensive hands-on experience delivering FDA-compliant submission packages, including annotated CRFs, SDTM and ADaM datasets, reviewer guides (ADRG and cSDRG), and high-quality Tables, Listings, and Figures (TLFs). He has contributed to multiple Integrated Summaries of Safety (ISS) and Efficacy (ISE), pharmacovigilance reports (DSUR, PSUR, PBRER), and global regulatory submissions, including FDA and PMDA (Japan). His work consistently meets the highest standards of accuracy, traceability, and regulatory compliance. Throughout his career, Srinivas has collaborated closely with biostatisticians, data managers, and clinical teams to design, develop, validate, and QC complex safety and efficacy datasets. He is highly proficient in SAS/BASE, SAS/Macro, SAS/STAT, SAS/GRAPH, SAS/ODS, and SAS/SQL, and regularly leverages Pinnacle 21 for SDTM and ADaM validation. His technical expertise also includes survival analysis, PK/PD and exposure-response datasets, NONMEM data preparation, and advanced statistical outputs such as Kaplan-Meier plots and forest plots.
Srinivas holds a Master of Science in Information Systems Technologies from Wilmington University and a Bachelor of Pharmacy from Osmania University. He is a BASE SAS certified professional and a Registered Pharmacist, uniquely combining technical programming excellence with strong domain knowledge in drug development and clinical research. He is known for his reliability, attention to detail, and ability to deliver high-quality clinical programming solutions in fast-paced, submission-driven environments.