Principal Statistical Programmer

Role: Principal Statistical Programmer leading clinical trial data analysis and submission activities. Objectives include ensuring quality, compliance, and timely delivery of statistical outputs for clinical development programs. Responsibilities cover SAS programming, quality control, supporting regulatory submissions (eCTD, ISS/ISE), and collaborating with cross-functional teams like Biostatistics, Data Management, and Regulatory Affairs. Requirements: Bachelor's in a Scientific discipline; 8+ years in biotech/pharma/clinical research with expertise in SAS, CDISC standards, and regulatory submissions. Preferred: advanced knowledge of clinical trial processes and regulatory standards. HighValue: extensive SAS proficiency, regulatory submission experience, validation of electronic data submissions, and compliance with FDA/ICH/GCP. Work setup: remote, hybrid, or onsite option with flexibility; no travel specified.