Job Description

Requirements:

B.Sc., M.Sc., or equivalent education in Biostatistics/Statistics, Bioinformatics, Life Sciences, Mathematics, Physical Sciences, or related fields
dvanced SAS macro programming experience is required for the development of global tools that will increase the efficiency and capacity of the Statistical Programming group
t 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
bility to work on multiple collaborative projects, team player mentality

Responsibilities :

s 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

Job Tags

Work experience placement

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