Statistical Programmer II
Core
Statistical programming for clinical studies, developing and maintaining SDTM/ADaM datasets, tables, figures, and listings (TFLs) in compliance with regulatory guidelines.
Role type
Mid-level IC statistical programmer (clinical data)
Builds
SDTM, ADaM, and analysis datasets, tables, figures, and listings (TFLs) for clinical studies
Domain
Clinical research / Biostatistics
Required skills
SAS programming, CDISC standards (SDTM/ADaM), clinical study protocol review, data transformation, documentation, regulatory compliance
Preferred skills
Mentorship of junior staff, SAS macro development, risk mitigation planning
Technologies
SAS, CDISC standards
Responsibilities
Develop and maintain SDTM and ADaM specifications; Program SDTMs, ADaMs, TFLs according to specifications; Review clinical study protocols for programming responsibilities; Mentor junior staff; Ensure compliance with regulatory guidelines and SOPs
Seniority
Mid-level, hands-on IC