Senior Statistical Programmer-India
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 Committees, Interim Analyses, and Clinical Study Reports
Domain
Pharmaceutical clinical research / Biostatistics
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, Master's degree in Statistics/Computing Sciences, French language
Technologies
SAS, Pinnacle 21, XML, eCRF
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 (via careerplan.io/jobs/15-003-3C-27A-senior-statistical-programmer-india)
Seniority
Senior, hands-on IC with lead responsibilities