Senior Statistical Programmer/Analyst Consultant (TA -Gene Therapy)-Remote
Core
Lead study-level statistical programming activities for Gene Therapy clinical trials from study start-up through database lock, analysis, and reporting.
Role type
Senior Statistical Programmer Consultant (Gene Therapy)
Builds
Clinical datasets, statistical outputs (TLFs), and regulatory submission materials for Gene Therapy trials
Domain
Biotechnology / Gene Therapy / Clinical Trials
Required skills
SAS programming, CDISC standards (SDTM, ADaM), clinical trial data management, regulatory compliance, study-level programming leadership, TLF development, data validation
Preferred skills
Oncology or Internal Medicine clinical trial experience, mentorship of junior programmers
Technologies
SAS, CDISC SDTM, CDISC ADaM
Responsibilities
Develop and validate SAS programs for SDTM, ADaM, and TLFs; Collaborate with Biostatisticians on protocols and SAPs; Manage study-level programming timelines and quality; Support interim and final analyses and regulatory submissions; Provide technical guidance and mentorship to other programmers
Seniority
Senior, hands-on IC with mentorship responsibilities
