Senior Statistical Programmer-Argentina
Core
Lead statistical programming for clinical trials, developing and validating CDISC-compliant datasets (SDTM, ADaM) and TLFs for regulatory submissions.
Role type
Senior IC statistical programmer (clinical trials)
Builds
SDTM, ADaM, and TLF datasets for Data Monitoring Committee reviews, Interim Analyses, and Clinical Study Reports
Domain
Biotechnology / Pharmaceutical clinical research
Required skills
SAS programming, CDISC standards (SDTM, ADaM), XML programming, Pinnacle 21 validation, ICH guidelines, clinical trial data management
Preferred skills
SAS certification, CDISC certification, French language
Technologies
SAS, Pinnacle 21, XML (via careerplan.io/jobs/15-003-3C-278-senior-statistical-programmer-argentina)
Responsibilities
Develop/maintain/validate aCRFs, SDTM, ADaM, and TLFs; Review SAPs and TLF shells; Support data cleaning and issue resolution; Validate datasets using Pinnacle 21; Mentor junior programmers
Seniority
Senior, hands-on IC