Radhika Aitha is an accomplished statistical programming professional with more than 10 years of experience in clinical data management, statistical programming, and regulatory submissions within the pharmaceutical and healthcare industries. Throughout her career, she has specialized in supporting Phase I, II, III, and IV clinical trials, with expertise spanning study design, data standardization, analysis dataset development, and regulatory-compliant reporting. Her technical proficiency includes Base SAS, SAS/MACROS, SAS/SQL, SAS/STAT, SAS/ODS, SAS/GRAPH, R, Python, SQL, and CDISC standards including SDTM and ADaM. She also possesses strong knowledge of FDA regulatory requirements, including IND and NDA submissions, ISS and ISE preparation, and compliance with 21 CFR Part 11.
Currently serving as Manager, Statistical Programming at IT Caps supporting Arcellx Pharma, Radhika leads statistical programming activities for clinical studies while overseeing project deliverables, resource planning, quality control, and stakeholder communication. She develops programming specifications based on Statistical Analysis Plans, supports FDA submission activities, performs exploratory data analysis using R, executes Pinnacle 21 validation, and contributes to project proposals and client presentations. Prior to this role, she held a similar management position at MMS Holdings, where she was responsible for statistical programming oversight, client engagement, and FDA submission support.
Previously, Radhika worked as a Senior Statistical Programmer at Parexel International, supporting oncology studies for Novartis and GlaxoSmithKline. In this role, she led statistical programming activities, developed CDISC-compliant SDTM and ADaM datasets, conducted data cleaning and transformation using SAS and R, created safety and efficacy datasets, performed quality control, collaborated with biostatisticians, managed project timelines and resources, and served as the primary programming contact for sponsors. She also gained extensive experience with Pinnacle 21 validation and regulatory terminology management.
Earlier in her career, Radhika served as Lead SDTM Implementer at Sapere Data (supporting Cytel and Amgen), where she led CDISC implementation, SDTM annotation, validation, FDA submission preparation, transport file generation, and process improvement initiatives. She also worked as a Senior Applications Programmer at Procal Technologies, contributing to SDTM mapping, ADaM dataset creation, SAS macro development, clinical reporting, and analysis programming for clinical studies. She began her career as a Clinical Data Analyst at WeUMe Infosys, where she focused on clinical data analysis, data validation, statistical reporting, and preparation of tables and listings for clinical research.
In addition to her extensive industry experience, Radhika has completed training in AI for Life Sciences, Machine Learning in Healthcare, Clinical Research and Data Management, Python, R, SQL for biological data analysis, AI/ML frameworks including TensorFlow, PyTorch, and Hugging Face, as well as NLP models and chatbot evaluation techniques. She combines deep expertise in statistical programming, clinical research standards, and regulatory compliance with leadership experience in delivering high-quality programming solutions that support clinical development and regulatory submissions.