Sr Statistical Programmer

ICON plc • Blue Bell, SD

4d

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patient 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.

Requirements

• 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.

Nice To Haves

• Experience in managing ADaM standards

Responsibilities

• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior