Principal Statistical Programmer Consultant – Oncology (Solid Tumors)-Remote

Role overview

Provide senior programming leadership for clinical development studies, primarily in solid tumor oncology. The work spans clinical trial data standards, statistical analyses, and regulatory deliverables across Phase I–III programs, with close coordination among biostatistics, data management, and clinical teams.

Responsibilities - Lead statistical programming work for oncology trials and oversee delivery quality and timelines. - Develop, validate, and maintain SDTM and ADaM datasets in line with CDISC standards. - Program and review complex tables, figures, and listings for study reports and regulatory submissions. - Support safety and efficacy analyses covering endpoints such as overall survival, progression-free survival, response rate, and duration of response. - Apply Kaplan–Meier methods, Cox models, and other time-to-event analyses. - Review specifications, datasets, and outputs; mentor programmers and improve programming processes. - Assist with submissions and responses to health authority questions as needed.

Requirements - Bachelor’s or master’s degree in statistics, biostatistics, mathematics, computer science, or a related field. - Extensive statistical programming experience in pharmaceutical or biotechnology clinical research. - Strong SAS skills, including Base, Macro, and SAS/STAT. - Significant experience with solid tumor trials, ideally spanning Phase I, II, and III. - Expertise in CDISC SDTM and ADaM, oncology endpoints, and complex TFL development and validation. - Knowledge of ICH-GCP and FDA or EMA regulatory requirements, with strong communication and cross-functional collaboration skills.

Nice to have

Experience with immuno-oncology or targeted therapies; studies in head and neck, lung, colorectal, breast, or other solid tumors; regulatory submissions; and technical leadership or mentoring.