Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

6 years minimum

Working hours

Regular working hours

Languages

English

Job source

www.careerjet.com

Tech stack

Bioinformatics Coherent Remote File System (CRFS) R (Programming Language) SAS (Software) Extensible Markup Language (XML)

Job description

• 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

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

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Apply on www.careerjet.com

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