Teams at Orion Corporation

Lead development, validation, and delivery of clinical trial analysis datasets and submission-ready outputs (ADaM, TLFs, define.xml) following CDISC and regulatory standards. Support data cleaning, submission packages (Pinnacle 21), automation/AI-assisted workflows, and mentor junior programmers across Phase I-III oncology studies.

Lead clinical data management for oncology Phase I-III trials from startup through database lock. Design and review eCRFs and database builds, manage external data integration (imaging, genomics, biomarkers, ePRO), ensure CDISC/SDTM readiness, oversee queries, coding, regulatory submission support, and drive data quality and automation initiatives.

Provide statistical design, analysis, interpretation, and reporting support for Phase I-III oncology trials with emphasis on biomarker, translational, and precision medicine analyses. Develop SAPs, mock TLFs, execute and validate analyses, ensure CDISC compliance, collaborate with clinical, programming, and translational teams, and contribute to regulatory submissions and scientific communications. Support evaluation of AI-assisted tools and automation to improve statistical workflows.