What are the responsibilities and job description for the Statistical Programmer position at Katalyst CRO?
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
- 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