[Hiring] Principal Clinical Data Standards Consultant @ICON plc

Role Description

As a Principal Clinical Data Standards Consultant at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Your focus will be on coordinating consulting and advisory services delivery, resolving issues, and developing team capability.

• Developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards.
• Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials.
• Developing and maintaining training and reference materials related to standards topics including CDASH, SDTM, Terminology, ADaM, define-XML and regulatory submission requirements.
• Managing the development and maintenance of data management processes and tools.
• Keeping abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices.

Qualifications

• Bachelor's degree in life sciences, computer science, or a related discipline.
• SDTM expert with a background that includes programming in SAS, R and other languages.
• Minimum of 8 years experience in the industry in roles that demonstrate the knowledge and skill in the above.
• Statistical programming role focused on SDTM tasks.
• Demonstrated leadership skills.
• Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry.
• Advanced Proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e.g., FDA, EMA).
• Excellent analytical and problem-solving skills with a keen attention to detail.
• Excellent communication and collaboration abilities to work effectively in cross-functional teams.
• Willingness to travel as required (approximately 15%).

Requirements

• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.