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

📋 Description

• Lead statistical programming activities for Gene Therapy clinical trials from study start-up
• Develop, review, and validate SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs).
• Collaborate with Biostatisticians to interpret study protocols, Statistical Analysis Plans (SAPs)
• Develop and validate clinical datasets and statistical outputs for safety and efficacy analyses.
• Support interim and final analyses, database lock activities, and Clinical Study Report preparation.
• Ensure programming deliverables comply with CDISC standards and applicable regulatory requirements.

🎯 Requirements

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a
• Significant experience in clinical trial statistical programming within a pharmaceutical
• Hands-on experience supporting Gene Therapy clinical trials is required.
• Strong proficiency in SAS programming.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Experience developing and validating clinical trial TLFs.