Principal Statistical Programmer

Role: Principal Statistical Programmer supporting clinical trial data analysis and submission activities within a targeted oncology company. Responsibilities: develop and validate CDISC-compliant SDTM and ADaM datasets, TLFs, and submission documents; ensure quality, traceability, and regulatory readiness of programming outputs; collaborate with cross-functional teams including Biostatistics, Data Management, and Clinical Operations; lead initiatives to develop programming standards and reusable tools; validate external vendor datasets; support regulatory submissions, including NDA processes. Requirements: Master’s degree in Statistics, Computer Science, or related field; 4+ years industry experience in biotech/pharma; strong SAS programming expertise; knowledge of clinical trial processes, CDISC standards, and regulatory guidelines; prior NDA submission experience preferred; oncology/hematology experience highly desirable. HighValue: oncology, targeted therapies, CDISC standards, regulatory submissions, SAS, cross-functional collaboration in clinical development. WorkSetup: not specified.