Senior Principal, Biostatistical Programming

Role: Senior Principal Biostatistical Programmer leading data processing and analysis for Phase I–III clinical trials in a biopharma setting. Responsibilities: perform SAS programming to generate analysis datasets, ensure CDISC compliance, develop macros, validate outputs, review SAP and datasets, and oversee programming quality and timelines for studies; act as project lead and mentor to team members, collaborate with CROs, and support submission activities. Requirements: strong SAS/Base/Macro skills, knowledge of CDISC standards, several years of experience in biopharma or CRO, degree in statistics/computer science or equivalent experience, and project leadership abilities. Preferred: experience with regulatory submission standards and data management. High-Value: focus on clinical data analysis for hematology, oncology, or inflammatory autoimmune indications; involvement in Phase I–III trials; emphasis on GxP, regulatory compliance, CDISC, and cross-functional teamwork. Work setup: not specified; requires effective multitasking and leadership in a dynamic environment.