Play a key role in creating high-quality, submission-ready clinical data packages. From mapping study data to CDISC requirements, developing define-XML to validating CDISC deliverables, your work directly contributes to reliable clinical research and drug development.
What you will do. As a CDISC Programmer (SAS), you’ll focus on transforming clinical study data into standardized, high-quality CDISC deliverables. You’ll contribute to the development, mapping, documentation, and validation of SDTM datasets and associated metadata.
Your tasks include, among others:
- Developing SAS programs to create SDTM datasets
- Annotating CRFs and generating Define-XML
- Validating SDTM domains and reviewing annotated CRFs
- Setting up Data Transfer Agreements (DTA)
- Opportunity to work on ADaM domains in the future
What they ask You are an experienced SAS programmer with strong CDISC expertise and a focus on quality. You have a proactive mindset, work accurately, and are eager to contribute to innovative drug development. You work accurately, communicate clearly, and collaborate effectively with colleagues while also being able to work independently. You stay calm and focused, even when working under pressure or during tight deadlines.
What they ask
- Advanced CDISC programming skills, including experience with Controlled Terminology, Reviewer’s Guides and generating annotated CRFs, SDTM domains, define-XML
- Experience using Pinnacle 21
- Knowledge and understanding of the ICH Guidelines, FDA Industry Guidelines, and GCP principles
- Good English written and oral communication skills
Preferences.
- Experience in creating Tables, Listings and Figures (TLFs) and ADaM domains is preferred
How to apply
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