SDTM Programming Lead

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center 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.

We have an incredible opportunity for a Clinical Data Programming Lead (SDTM) to join the team.

Location: (home-based OR office-based)

• United States
• Canada
• Mexico
• Colombia
• Argentina
• Brazil

Overview of the role:

The Clinical Data Programming Lead (CDPL) is part of the Clinical Data Services (CDS) group involved in clinical data receipt, programming and delivery. The CDPL is responsible for overseeing the set-up and maintenance of clinical data deliverables on multiple clinical studies.

The CDPL participates in activities as related to the specification, validation and quality assurance of study data deliverables and applies competent experience and knowledge in support of the clinical data programmers assigned to a clinical study.

• Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets
• Build SDTM data set specifications per specified study requirements
• Program data sets per specification, and validate data sets per the formal, documented QC process
• Build data programming specifications per specified study requirements
• Program clinical data programs per specification
• Validate clinical data programs per the formal, documented QC process
• Execute programs and generate clinical data outputs to according to study/client requirements
• Review and quality assure CRF annotations produced by other programmers
• Participate in testing of clinical data system upgrades and documenting of test scripts when required
• Lead programming and validation activities across a single project, ensuring that timelines are met and deliverables are of sufficient quality
• Travel (approximately 15%) domestic and/or international

To be successful, you will need:

• 4+ years of experience in clinical data programming and delivery
• Demonstrated ability to produce CDISC and sponsor defined clinical data deliverables
• Experience building SDTM data set specifications
• Experience annotating CRFs in accordance with CDISC or sponsor specific guidelines
• Ability so successfully handle multiple tasks and timelines
• Team player with strong verbal and written communication skills
• Advanced knowledge of the clinical data programming development life cycle
• Bachelor’s degree in information systems, science or related discipline

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 through the form below.

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