Senior SDTM Programmer

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Summary of SDTM Programmers’ responsibilities:

• Interact with vendors to receive CRF & external data. Review data transfer specs to ensure data is in a form we can use (SAS compliant variable names, follow Otsuka standards and specific compound templates, file format is something we can use with little manipulation).
• Review CRF & external data received. Compare datasets and vendor annotated CRF to ensure all expect fields are captured – these datasets are then used to build the SDTM datasets.
• Write SAS programs to compare CRF data and External data (LAB, ECG, PK, EEG…) – compare subject id, visit, date, time, accession number. Reports are then given to data managers for reconciliation and to issue queries.
• Create Trial Design Domains based on protocol/CRF.
• Use a GUI interface (DSP) to create SDTM datasets. Using a series of boxes following arrows across the screen to layout the flow of data and the computations needed. This is “SAS-like” but is not using SAS directly to program the SDTM datasets. When you execute what is created in GUI environment, the system then writes SAS code to build the datasets. Takes some detective work to figure out what went wrong by looking at temporary and output datasets, and behind-the-scenes SAS code that gets written.
• Create SDRG and SDTM define
• QC SDTM datasets, specs, docs, annotations that other programmers create.
• Troubleshooting and SAS programming to create tools for the team – such as create a SAS programs to convert .csv/.xlsx/.dat files to SAS datasets. Or create programs to do full Proc Compare of a study’s database (new data versus old data) that can be used as a standard across studies.
• Interacting with data managers, clinical programmers, statisticians, medical coders, external data vendors.
• Running Pinnacle 21 to validate SDTM datasets.

Qualification:

• 5 years' experience working with SDTM
• University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree
• Bases SAS programming skills and Certified SAS Programmer are most preferred.
• Attributes: well versed in building, mapping, annotating, QC’ing, and understanding flow of SDTM data. Attention to detail. Problem solver. Good at working in teams. Familiar with writing code for edit checks and data reconciliation. Good documentation practices.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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