Clinical Data Standard Consultant

Senior Statistical Programmer ICON plc is a world‑leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. A Principal Clinical Data Standards Consultant is responsible for supporting the operational staff in the use of ADaM and the define.xml capture for statistical analysis within the Medidata standard. They will develop tools to increase the efficiency, timeliness and quality of deliverables for data collection, tabulation, analysis and reporting. They will also define and collect metrics about the use of standards. They will participate in the development of training of the operational staff in the areas of their expertise. What You Will Do: Serve on Sponsor Standards and Technology Leadership teams. Consult with clients on sponsor‑specific CDISC centric implementation projects. Participate in industry groups focused on the development of standards related initiatives (e.g. CDISC, PhUSE). Author, maintain, implement, and report status for Standards Related Project Plans. Responsible for the implementation, strategy, and configuration of a metadata repository used to manage libraries of CDISC related metadata, terminology and related standards. Mentor Clinical Data Standards Consultants and lead Subject Matter Expert teams on topics relevant to standards. Identify areas for process improvement which may increase productivity, quality and/or compliance of deliverables in the areas from data collections through analysis and reporting. Participate in the analysis of metrics and in creating recommendations to the management teams on process improvements together with the Director of Global Data Standards. Your Profile: Minimum of 5 years of experience in industry in a role demonstrating knowledge of standards used by biometrics. An undergraduate degree or international equivalent from an accredited institution. Demonstrated expertise in CDASH, SDTM standards and associated controlled terminology with a good understanding of CRF design concepts. Excellent communication skills with demonstrated leadership ability. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family. Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well‑being. Life assurance Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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 or submit a request. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click to apply. #J-18808-Ljbffr