Principal Clinical Data Standards Consultant - SDTM

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.

Level-Specific Responsibilities

• Defines and implements core ICON, sponsor, and therapeutic area standards for the purpose of increasing efficiency, productivity and quality of deliverables of industry standards (CDASH, SDTM, ADaM) and deliverables of clinical study report appendix tables, figures and listings.

• Manages the development and maintenance of training and reference materials related to end-to-end standards topics including but not limited to: CDASH, SDTM, Terminology, ADaM, compliance checking, define-XML, analysis displays, and regulatory submission requirements.

• Serves as and/or supports the library managers with the implementation and maintenance of libraries of CDISC standards.

• Manages the development and collection of metrics about the use of standards at ICON and analyzes them to detect process improvements.

Knowledge, Skills and Abilities

• 8 - 13 years of relevant experience in CDASH/DB build , SDTM, ADAM.

• Advanced knowledge of clinical programming aspects of clinical research, data management, standards compliance methodologies, metadata management and data analysis

• Advanced knowledge of programming, analysis, and reporting or data collection standards

• Advanced knowledge of CDISC standards for the creation and maintenance of end-to-end standards from data collection to regulatory submission

• Advanced knowledge of all CDISC guidance documents and implementation guides, as well as FDA, EMA and PMDA guidance and regulations regarding electronic submission of data

• Excellent written and oral communication skills, along with ability to present technical issues

• Advanced ability to work with management in the development and collection of metrics

• Advanced ability to collaborate with sponsors on standards implementations Previous experience using computerized information systems; experience with PC Windows and word processing

• Demonstrated experience applying at least one data standard such as: CDASH, SDTM and ADaM

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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