Clinical SAS Programmer at Centre for Human Drug Research

CHDR is looking for a SAS Programmer for 24 – 40 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 Clinical SAS programmer you are involved in a clinical study from beginning to end.  
You will be responsible for translating clinical protocols into operational databases and will be managing these databases after they go live. During the study and afterwards you are responsible for generating safety reporting (TLFs), processing electronic data files and setting up transfer files as per DTA/DTS. 
As CHDR’s databases are used by all operational staff, this position requires close communication with other departments. The databases are critical to both clinical trial execution as well as the analysis and processing of data. Our database software Promasys uses a GUI and does not require knowledge of programming syntax. 
Our Data Programming team currently consists of 6 members with different specializations. We all like to learn and develop, so we share our knowledge. Does this appeal to you, then do not hesitate to contact us.  
 
Required skills 

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

  • Experienced in creating Tables, Listings and Figures; 

  • Expertise in defining/building study databases (eCRF) and creating edit checks; 

  • Expertise in CDISC (Controlled Terminology, SDTM, ADaM, define-XML, Annotated CRF) is preferred; 

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

  • 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 interim and final safety analysis reports, transfer files and transform received data to the requested format; 

  • Validating SAS programs and perform output validations; 

  • Reviewing study protocols; 

  • Defining study databases including edit checks (at CHDR we use the integrated clinical data management and EDC system Promasys®); 

  • Reviewing and writing Data Transfer Plans; 

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

  • Validating SDTM domains and define-XML; 

  • 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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