B.Sc., M.Sc., or equivalent in Biostatistics/Statistics, Bioinformatics, Life Sciences, Mathematics, or Physical Sciences
Advanced SAS macro programming experience to develop global tools
6+ years in clinical trials with SAS programming, analysis, and reporting
Experienced with Pinnacle21 validation and generating Define.xml
Extensive knowledge of CDISC standards and SDTM/ADaM datasets
Strong verbal and written English communication skills
Demonstrated knowledge of clinical drug development
Proficient in advanced statistical analyses
Independent, detail-oriented, and accountable for quality and timely delivery
Team player with ability to manage multiple collaborative projects.
Responsibilities
Utilize SAS and R programming to prepare SDTM and ADaM datasets, plus TLFs and related documentation for clinical trials
Conduct quality control and assurance on datasets and outputs
Participate in initiatives to enhance efficiency in statistical programming processes
Collaborate with teams of programmers, statisticians, and consultants on various client projects across therapeutic areas
Support all phases of clinical trials, from Phase 1 to Phase 4.
Benefits
Flexible work arrangements
Opportunities for professional development and training
Collaborative work environment that emphasizes teamwork
Engagement in diverse projects with various therapeutic focuses
Participation in company initiatives aimed at improving processes.
Full 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
