CDISC Programmer (SAS)

Centre for Human Drug Research; Netherlands; Hybrid; EUR 42,000 - 64,000; Full time

Job summary

CHDR in Leiden, Netherlands, is seeking a CDISC Programmer (SAS) to transform clinical study data into CDISC deliverables. You will map study data to CDISC requirements, develop define-XML, and validate SDTM datasets in a collaborative, fast-paced environment.

The role offers a one-year contract for at least 32 hours per week, a competitive salary (€3,803–€5,755 per month), a strong pension, vacation allowance, and ongoing training opportunities near Leiden Central Station.

Qualifications

• Advanced CDISC programming skills including terminology and annotated CRFs.
• SDTM domain knowledge and define-XML generation.
• Experience with SDRG and CDISC standards.
• Strong English communication skills.

Responsibilities

• Develop SAS programs to create SDTM datasets.
• Annotate CRFs and generate Define-XML.
• Validate SDTM domains and review annotated CRFs.
• Set up Data Transfer Agreements (DTA).
• Opportunity to work on ADaM domains in the future.

Skills

CDISC programming

SAS programming

SDTM datasets

Define-XML

Tools

Pinnacle 21

Job description

Join CHDR as a CDISC Programmer (SAS) and play a key role in creating high-quality, submission-ready clinical data packages. From mapping study data toCDISC requirements,developing define-XMLtovalidating CDISC deliverables, your work directly contributes to reliable clinical research and drug development. At CHDR,you’llbe part of a collaborative environment where quality,expertise, and impact go hand in hand.

This position is only open to candidates who are currentlyresidingin the Netherlands. Applications from candidates living outside the Netherlands will not be considered.

What does the job look like?

As a CDISC Programmer (SAS) at CHDR,you’llfocus on transforming clinical study data into standardized, high-quality CDISC deliverables.You’llcontribute to the development, mapping, documentation, and validation of SDTM datasets and associated metadata.

You’llbe part of a close-knit and collaborative team with diverse backgrounds andexpertise. We value open communication, continuous learning, and helping each other grow. Whetheryou’resolving a programming challenge or ensuring a CDISC package meets the required standards,you’llwork in an environment where your contribution truly matters. Your tasks include, among others:

• Developing SAS programs to create SDTM datasets
• AnnotatingCRFsandgeneratingDefine-XML
• ValidatingSDTMdomainsandreviewingannotated CRFs
• Setting up Data Transfer Agreements (DTA)
• Opportunity to work onADaMdomains in the future

What CHDR offers you

We offer you a one-year contract for a minimum of 32 hours per week. The corresponding terms of employment below are based on a 40-hour workweek.

• Salary between €3,803and €5,755per month, depending on your experience.
• You will build up a good pension with ABP, receive 8% vacation allowance, and a year-end bonus ranging from 3.8% to 12%.
• 25 vacation days per year, plus 1 Diversity Day.
• Opportunities for personal development through training courses,certifications,or conference attendance,fully funded by CHDR.
• Our office is in a prime location: right next to Leiden Central Station, making it perfectly accessible by public transport. Your travel costs will be reimbursed up to 100%, or you can choose topurchasean (electric) bicycle at a reduced rate.

You will join a dynamic, passionate organization and work within a diverse team in a fast-paced, innovative setting. We offer you a pleasant hybrid workplace with an open, multidisciplinary workenvironment, where we pay close attention to team spirit and a healthy work-life balance. Fun activities are also organized regularly, such as Friday afternoon drinks, a summer BBQ, a weekend in the Ardennes, and our annual Christmas dinner.

What you bring to CHDR

You are an experienced SAS programmer with strong CDISCexpertiseand 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. Additionally, we ask for the following knowledge and experience:

• Advanced CDISC programming skills, includingexperience withControlled Terminology, Reviewer’s Guidesandgeneratingannotated CRFs, SDTMdomains, define-XML,and SDRG.
• Experience using Pinnacle 21.
• Experience in creating Tables, Listings and Figures (TLFs)andADaMdomainsis preferred.
• Knowledge and understanding of the ICH Guidelines, FDA Industry Guidelines, and GCP principles.
• Good English written and oral communication skills.

Who are we?

Since 1987, our enthusiastic and ambitious team at CHDR has been committed to conducting high-quality clinical research into the effects of both new and existing medicines. As anon-profit foundation, we take pride in contributing to scientific progress and the advancement of drug development. CHDRis located inLeiden and works in close collaboration with Leiden University and the clinical departments of the Leiden University Medical Center (LUMC).

Centre for Human Drug Research, Zernikedreef 8, 2333 CL Leiden, the Netherlands. Tel.: [phone].