Senior Statistical Programmer-Philippines
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) (via careerplan.io/jobs/15-003-3C-27B-senior-statistical-programmer-philippines)
Builds
SDTM, ADaM, and TLF datasets for Data Monitoring Committee reviews, Interim Analyses, and Clinical Study Reports
Domain
Pharmaceutical clinical research / Dermatology
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, Master's degree in Statistics
Technologies
SAS, Pinnacle 21, XML, eCRF
Responsibilities
Develop/maintain/validate aCRFs, SDTM/ADaM specifications and datasets, TLFs, and define.XMLs; Review SAPs and TLF shells; Support data cleaning and issue resolution; Act as Lead/Unblinded Programmer for randomization and IAs; Mentor junior programmers
Seniority
Senior, hands-on IC with lead responsibilities