Job Title

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 SAS Lead experience overseeing other programmers and projects In-depth experience with CDISC, SDTM and ADaM standards in Phase 2 - 3 trials Experience using Pinnacle 21 Strong organizational skills High degree of accuracy with timelines and ability to meet deadlines Strong verbal and written communication skills Strong leadership skills Ability to multitask in a fast-paced environment What you will be doing: Act as the Lead Programmer Responsible 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 deliverables In collaboration with Principal Biostatistician: update ADaM specifications, program/review ADaM datasets, and review TLFs programmed by junior staff Program tables, listings and figures as per SAP for clinical research studies Import data from 3rd party clients (e.g. central lab transfers) Prepare data exports to be sent to clients Perform data checks (quality control) as needed to ensure integrity and accuracy of data displays Support CDM group in validation of clinical data Undertake project management activities as needed, including managing project team of statistical programmers, ensuring timely completion of deliverables with high quality