Requirements: B.Sc., M.Sc., or equivalent education in Biostatistics/Statistics, Bioinformatics, Life Sciences, Mathematics, Physical Sciences, or related fields Advanced SAS macro programming experience is required for the development of global tools that will increase the efficiency and capacity of the Statistical Programming group At least 6 years of Clinical trials related work experience in SAS programming, analysis and reporting in the context of drug development projects is required Well experienced in Pinnacle21 validation process, generating define xml using Pinnacle 21 Extensive experience in implementing CDISC standards, as well as annotating CRFs, creating specifications for SDTM and ADaM datasets Experienced in creating Define.xml and the corresponding Reviewers' Guide for SDTM and ADaM datasets Good verbal and written communications skills in English Demonstrated knowledge of clinical drug development Proficiency in conducting advanced statistical analyses Must be independent, attention to detail, accountable to quality and timely delivery Ability to work on multiple collaborative projects, team player mentality Responsibilities: As a Statistical Programming Consultant, you will use your SAS and R programming skills to prepare SDTM and ADaM datasets, Tables, Listings, & Figures (TLFs), as well as create related documents such as aCRF, programming specifications, and define packages (including reviewer's guides) for Phase 1 to Phase 4 clinical trials In addition, you will conduct quality control and quality assurance activities on datasets and outputs and may participate in company initiatives to improve the efficiency of end-to-end statistical programming activities, analysis, and reporting (IT, methodology, automation, quality) You will work closely in teams led by statistical programmers, statisticians, and drug development consultants, supporting a variety of client projects across various therapeutic areas and complexities
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