CDISC Programmer (SAS)

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

Benefits offered by this job

ABP pension

8% vacation allowance

Year-end bonus 3.8–12%

25 vacation days + Diversity Day

Fully funded training

Public transport subsidy / bike scheme

Job summary

Centre for Human Drug Research in Leiden, NL, is seeking an experienced CDISC Programmer (SAS) to transform clinical study data into standardized, high-quality CDISC deliverables. You will contribute to SDTM data, define-XML, and data validation within a collaborative team.

The role offers a 1-year contract for 32+ hours per week, with a competitive salary, ABP pension, vacation allowance, and a discretionary year-end bonus.

Qualifications

• Advanced CDISC programming skills including CDT terminology, reviewer’s guides, and generating annotated CRFs, SDTM domains, define-XML, and SDRG.
• Experience using Pinnacle 21.
• Experience creating Tables, Listings and Figures (TLFs) and ADaM domains is preferred.
• Solid understanding of ICH Guidelines, FDA Industry Guidelines, and GCP principles.
• Excellent written and oral 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

SAS programming

CDISC

SDTM

Define-XML

ADaM (domains)

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 to CDISC requirements, developing define-XML to validating CDISC deliverables, your work directly contributes to reliable clinical research and drug development. At CHDR, you’ll be part of a collaborative environment where quality, expertise, and impact go hand in hand.

This position is only open to candidates who are currently residing in 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’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.

You’ll be part of a close-knit and collaborative team with diverse backgrounds and expertise. We value open communication, continuous learning, and helping each other grow. Whether you’re solving a programming challenge or ensuring a CDISC package meets the required standards, you’ll work in an environment where your contribution truly matters. 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 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 €3,803 and €5,755 per 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 to purchase an (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 work environment, 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 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. Additionally, we ask for the following knowledge and experience:

• Advanced CDISC programming skills, including experience with Controlled Terminology, Reviewer’s Guides and generating annotated CRFs, SDTM domains, define-XML, and SDRG.
• Experience using Pinnacle 21.
• Experience in creating Tables, Listings and Figures (TLFs) and ADaM domains is 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 a non-profit foundation, we take pride in contributing to scientific progress and the advancement of drug development. CHDR is located in Leiden and works in close collaboration with Leiden University and the clinical departments of the Leiden University Medical Center (LUMC).

Excited to join us?

Join our mission to improve clinical research through smart data solutions. Any questions about the position? Feel free to contact Jelle van Hasselt (Team Leader Clinical Programming) at 071-7517136.