Sr Statistical Programmer

Sr. 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.

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.

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.

Our benefits examples include:

• 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 specialized 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, subsidized 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, 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 or submit a request here

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 here to apply