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)
Builds
Production statistical datasets (SDTM, ADaM), TLFs, and submission packages for clinical study reports and interim analyses.
Domain
Pharmaceutical/CRO industry, clinical data management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAS programming, CDISC standards (SDTM, ADaM), Pinnacle 21 validation, XML programming, clinical trial data analysis, regulatory guidelines (ICH, FDA, Health Canada)
Preferred skills
SAS certification, CDISC certification, XML expertise, French language
Technologies
SAS, Pinnacle 21, XML, eCRF systems
Responsibilities
Develop and validate aCRFs, SDTM/ADaM specifications and datasets, TLFs; Review SAPs and DM documents; Support data cleaning and issue resolution; Act as Lead/Unblinded Programmer for randomization and IDMC reviews; Mentor junior programmers; Contribute to internal efficiency initiatives.
Seniority
Senior, hands-on IC with lead responsibilities
