Principal Statistical Programmer
Core
Lead statistical programming for clinical trial analysis, reporting, and data standardization (SDTM/ADaM) for pharmaceutical and medical device clients.
Role type
Principal Statistical Programmer (Clinical Trials)
Builds
CDISC-compliant datasets (SDTM, ADaM), analysis datasets, tables, listings, figures, and define.xml for regulatory submissions.
Domain
Clinical Research / Biostatistics / Regulatory Compliance
Required skills
SAS programming (Base, Stat, Macros, Graph), CDISC SDTM/ADaM standards, clinical trial design, statistical analysis, data validation, regulatory guidelines (FDA/CFR, ICH/GCP)
Preferred skills
SAS Base/Advanced/Clinical Trials Certification
Technologies
SAS, CDISC standards
Responsibilities
Lead statistical programming for large-scale, high-complexity clinical trial projects; develop and maintain SAS macro libraries and utilities; generate tables, listings, and figures per protocol and SAP; validate statistical programs and ensure CDISC/FDA compliance; mentor junior programmers; manage project timelines, budgets, and client expectations.
Seniority
Principal, hands-on IC with mentorship
