Principal Statistical Programmer FSP

Job description

The Principal Statistical Programmer works independently with only concept-level instruction and minimal supervision, tracks progress, and provides expert technical support to team members. This role also includes routinely briefing management on accomplishments, status, and issues, and serving as a project lead Statistical Programmer on clinical teams. Key Responsibilities: - Provide technical and project management leadership in SAS programming for analysis and reporting of complex clinical trial data, including Tables, Listings, and Figures (TLFs), and regulatory submissions (SDTM, ADaM in CDISC format) - Lead the development, review, and approval of documentation supporting data analysis, reporting, and regulatory submissions - Ensure compliance with company SOPs and regulatory requirements (FDA, ICH, GCP) - Participate in and lead technical meetings with internal and external stakeholders (e.g., CROs, FDA, EMA, partners) - Perform quality control (QC) and validation of SAS programs and outputs developed by other programmers - Review and contribute to define.xml and ADaM Reviewer’s Guides - Maintain and review study documentation per standard processes - Develop, test, and main...