Senior Statistical Programmer-South Africa
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
Clinical research / Biopharmaceuticals
Required skills
SAS, CDISC standards (SDTM, ADaM), XML programming, Pinnacle 21, ICH guidelines, Clinical trial data management
Preferred skills
SAS certification, CDISC certification, French language, Master's degree
Technologies
SAS, Pinnacle 21, XML
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
