Clinical Data Programming Lead (SDTM)

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

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

LOCATION OPTIONS

• United States (home-based OR office-based)
• Mexico (office-based with some remote flexibility)
• Canada (home-based OR office-based)

Summary:

This 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.

Highlights of Key Responsibilities:

• 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
• Validate data sets per the formal, documented CC process
• Build data programming specifications per specified study requirements
• Program clinical data programs per specification
• Validate clinical data programs per the formal, documented CC process
• Craft and maintain study documentation as required
• Execute programs and generate clinical data outputs to according to study/client requirements
• Review and quality assure CRF annotations produced by other programmers
• Review and quality assure supporting documentation produced by other programmers
• Participate in testing of clinical data system upgrades and documenting of test scripts
• Liaise with other ICON functions & sponsors
• Lead programming and validation activities across a single project, ensuring that timelines are met and deliverables are of sufficient quality

Requirements:

• Ideal candidate would have 4+ years of experience in clinical data programming
• Proven SQL & SAS programming experience with clinical data management experience
• Successfully handle multiple tasks and timelines
• Demonstrated ability to perform work you're leading individually
• Team player with strong verbal and written communication skills
• Proven ability to learn new technologies, applications and techniques
• Advanced knowledge of the clinical data programming development life cycle and clinical data programming concepts
• Associate's degree or higher in information systems, science or related discipline

Benefits of Working in ICON
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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.