ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
We are seeking someone who can support both the development and ongoing maintenance of our standard ADaM metadata. You will have a solid understanding of CDISC ADaM is essential for this role. Typically, individuals with experience as a statistical programmer are well suited for this position. Additionally, experience in managing ADaM standards would be a valuable plus.
What You Will Do:
Your experience in statistical programming will be key in delivering high-quality outcomes and mentoring colleagues.
Key responsibilities include:
- Develop, validate, and maintain ADaM datasets following CDISC standards and regulatory requirements (FDA, PMDA, EMA).
- Program and generate Tables, Listings, and Figures (TLFs) to support clinical study reports (CSRs).
- Collaborate with statisticians, data managers, and clinical teams to interpret analysis requirements.
- Create and maintain ADaM specifications (define.xml, metadata, reviewers guides).
- Perform quality control (QC) and validation of statistical programming outputs.
- Ensure compliance with company SOPs, industry best practices, and regulatory guidelines.
- Participate in study start-up activities, including annotation of CRFs and derivation specifications.
- Troubleshoot programming issues and propose efficient solutions.
- Support regulatory submissions and respond to health authority queries as needed.
- Contribute to continuous process improvement and standardization efforts.
Your Profile:
You will have a strong foundation in statistical programming, with the experience to work independently and guide others.
Required qualifications and experience:
- Bachelor's degree in statistics, computer science, mathematics, or a related discipline
- Significant experience in statistical programming within the clinical research or pharmaceutical industry.
- Strong proficiency in CDISC programming and a solid understanding of statistical concepts and methodologies.
- Excellent analytical skills, attention to detail, and the ability to manage multiple projects simultaneously.
- Strong communication and interpersonal skills, with the ability to work collaboratively within a multidisciplinary team.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Skills Required
- Bachelor's degree in statistics, computer science, mathematics, or related discipline
- Significant experience in statistical programming within clinical research or pharmaceutical industry
- Strong proficiency in CDISC ADaM programming and ADaM metadata management
- Ability to create and maintain ADaM specifications (define.xml, metadata, reviewer guides)
- Knowledge of regulatory requirements (FDA, PMDA, EMA) for clinical submissions
- Excellent analytical skills, attention to detail, and ability to manage multiple projects
- Strong communication and interpersonal skills for multidisciplinary collaboration
- Experience managing ADaM standards
ICON plc Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.
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Healthcare Strength — Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
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Leave & Time Off Breadth — Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
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Retirement Support — Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.
ICON plc Insights
What We Do
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
