At Takeda Pharmaceutical, I manage statistical programming pipelines for ISS initiatives across neuroscience, gastroenterology, and oncology. I pool and harmonize multi-study data from Phase I–IV trials and automate safety datasets and TLF outputs for Risk Management Plan reporting.
At Linical Accelovance, I led statistical programming for Phase I–III oncology trials, developing CDISC-compliant ADaM datasets and validating safety and efficacy outputs. I also programmed time-to-event and categorical endpoints, including PFS, OS, BOR, and ORR, for global regulatory submissions.
Earlier, at Puma Biotechnology and Novartis, I developed clinical datasets and statistical reports, supported ISS and eCTD submissions, and maintained SAS macro libraries. Across these roles, I’ve worked with CDISC standards, integrated data, validation, and submission materials including Define.xml and XPT files.
