SAS CDISC/SDTM Programmer (24-32 hours/week)

CHDR is looking for a SAS CDISC/SDTM Programmer for 24 – 32 hours a week

About the organization

CHDR is an independent institute specializing in innovative, early-stage clinical drug research (www.chdr.nl). By combining cutting edge methods and technologies, state-of-the-art facilities, and talented researchers, we help maximize our clients’ success. We are located in Leiden, the Netherlands, and collaborate closely with the University of Leiden and the clinical departments of the LUMC.

What does the job look like?

As SDTM programmer the main responsibility is to provide the complete SDTM submission package for selected studies. You convert the clinical study data from the database system (Promasys ®) into SDTM v3.3 using SAS and complete this with all necessary documents such as Define-XML and reviewers guide.

You have excellent knowledge on CDISC implementation and guidelines and are able to work with both existing SAS macros as well as setting up new scripts.

As a programmer you are also involved in generating safety reporting, processing electronic data files and setting up transfer files as per DTA/DTS.

Required skills

- At least 3 years of experience in SAS programming within the pharmaceutical industry/CRO;

- CDISC programming skills (Annotated CRF, SDTM, define-XML, Controlled Terminology, Reviewers guide);

- Experience in using Pinnacle 21;

- Knowledge and understanding of the ICH Guidelines, FDA Industry Guidelines and GCP principles;

- Experience in creating Tables, Listings and Figures is preferred;

- Good English written and oral communication skills;

- Team player;

- Feeling comfortable in an environment where working with stressful periods is common.

Responsibilities

- Developing SAS programs to create SDTM;

- Mapping study data to SDTM, including the define-XML;

- Set up of validation documentation;

- Developing SAS programs to create interim and final safety analysis reports, transfer files and transform received data to the requested format;

- Validating SDTM domains and define-XML;

- Knowledge about ADaM guidelines is preferred;

- Writing SOPS.

Our offer

You will join a dynamic, passionate organization and work within a small team in a multi-disciplinary environment. We offer you a pleasant workplace with an open multidisciplinary work environment and good secondary employment conditions such as an end of year bonus, development opportunities, and all kinds of social events.

Want to apply?

If you are interested in this position, please send an application with a motivation letter and cv to pz@chdr.nl. If you want some more information, please don’t hesitate to call Alexa Tibboel, Team Leader Data Programming, on 071-5246455.

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