CDISC SAS Programmer: SDTM/Define-XML Expert (NL)

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

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.