Senior Statistical Programmer/Analyst Consultant (TA -Gene Therapy)-Remote

Role overview Lead study level statistical programming for gene therapy clinical trials, supporting work from study start up through analysis and reporting. The role combines SAS programming, dataset and output validation, regulatory alignment, timeline ownership, and close collaboration with biostatistics and cross functional teams.

Responsibilities - Lead statistical programming deliverables across the clinical study lifecycle, including database lock, interim and final analyses, and reporting. - Develop, review, and validate SAS programs for SDTM and ADaM datasets and tables, listings, and figures. - Interpret protocols, statistical analysis plans, and specifications with biostatisticians. - Prepare and validate datasets and outputs for safety and efficacy analyses, including quality control. - Support clinical study report preparation and regulatory submissions, responding to programming questions. - Manage timelines and quality expectations, resolve complex issues, communicate risks, and guide other programmers.

Requirements - Bachelor’s or master’s degree in statistics, biostatistics, mathematics, computer science, or a related discipline. - Significant clinical trial programming experience in pharmaceutical, biotechnology, or contract research settings. - Hands on experience supporting gene therapy clinical trials. - Strong SAS skills and knowledge of CDISC standards, including SDTM and ADaM. - Experience developing and validating clinical trial tables, listings, and figures. - Ability to lead study programming independently and understand clinical trial processes, statistical analysis, and regulatory reporting. - Strong analytical, communication, and problem solving skills.

Nice to have Experience in oncology or internal medicine clinical development is also valued.

Benefits and work setup The position is described as remote and client facing, with independent work and collaboration with client counterparts and project teams. The listing indicates a contract arrangement.