Principal Clinical Data Standards Consultant

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.

OVERVIEW OF THE ROLE:

The Principal Clinical Data Standards Consultant will develop and implement ICON data standards libraries for SDTM, ADaM and TFL. They will support the development and implementation of macro libraries utilized in standards implementation.  They will provide internal and external consulting services on topics related to CDISC standards compliance and standards implementation. They will support sponsors on the development, implementation, maintenance, and governance of data standards content.

• Provide input in the development of training for both internal teams and for external sponsors on CDISC standards related topics

• Support the development and maintenance of technologies used for the implementation of data standards

• Provide sponsors with expert reviews of regulatory submission data packages for compliance with required data standards and submission readiness

• Participate in governance team meetings and provide standards input as necessary

• May perform expert reviews of study artifacts (i.e. eCRFs, programming specifications, datasets and define.xml files etc.)

• Participate in subject-level SME teams

• Contribute to development of initiatives for the department, possibly as project lead being responsible for other team members in a team lead role, but not as a line manager

• Lead others to solve complex problems while using sophisticated analytical thought to exercise judgement and identify innovative solutions

• Significantly impact the achievement of operational, project, or department objectives and ensures quality standards are achieved

• Travel (approximately 5%) domestic and/or international

TO BE SUCCESSFUL, YOU WILL NEED:

• 12+ years of related experience in data collections standards in the clinical research industry

• Advanced knowledge of SDTM and ADaM standards and of regulatory submission requirements pertaining to tabulation and analysis data

• Experience with witing complex SAS programs and macros using the creation of SDTM, ADaM and TFL deliverables

• Ability to apply expert knowledge of business challenges, and recommend best practices to improve products, processes or services to differentiate the business market

• Bachelor’s degree

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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