Summary:The Principal Statistical Programmer provides high quality programming solutions to support clinical studies in various therapeutic areas. They will work closely within a team of SAS programmers and Biostatisticians to support and perform analysis of clinical data.We are looking for someone who has:BA or BSc Degree in Statistics or Math Minimum of 7 years experience in clinical programming using SASLead experience overseeing other programmers and projectsIn-depth experience with CDISC, SDTM and ADaM standards in Phase 2 - 3 trialsExperience using Pinnacle 21Strong organizational skillsHigh degree of accuracy with timelines and ability to meet deadlinesStrong verbal and written communication skillsStrong leadership skillsAbility to multitask in a fast-paced environmentWhat you will be doing:Act as the Lead ProgrammerResponsible for SDTM package: author/review/update SDTM specifications, program/review SDTM datasets, validate SDTM datasets, author SDTM reviewers guide, and assess impact of protocol amendments to SDTM deliverablesIn collaboration with Principal Biostatistician: update ADaM specifications, program/review ADaM datasets, and review TLFs programmed by junior staffProgram tables, listings and figures as per SAP for clinical research studiesImport data from 3rd party clients (e.g. central lab transfers)Prepare data exports to be sent to clientsPerform data checks (quality control) as needed to ensure integrity and accuracy of data displaysSupport CDM group in validation of clinical dataUndertake project management activities as needed, including managing project team of statistical programmers, ensuring timely completion of deliverables with high quality
Job Title
Principal Statistical Programmer