Senior Statistical Programmer II

About the role

ICON Strategic Solutions is expanding its dedicated Biometrics Partnership with a key client and is looking for experienced Senior Statistical Programmers. Working in a sponsor-dedicated model, you will deliver statistical programming across clinical studies, supporting analysis, reporting and regulatory submissions, with exposure to traditional clinical development, oncology and real-world evidence programmes.

Key responsibilities

• Develop, validate and maintain complex SAS and R programs for clinical trial analysis and reporting
• Lead statistical programming for assigned studies and mentor less experienced programmers
• Create and review ADaM datasets, Tables, Listings and Figures (TLFs) and their programming specifications
• Work with statisticians, data managers and study teams to deliver regulatory-compliant outputs
• Support submission activities such as Define.xml and other regulatory deliverables
• Ensure deliverables meet CDISC standards, ICH-GCP guidelines and sponsor requirements
• Perform quality reviews, contribute to programming standards and process improvements, and give technical guidance

Required profile

• Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences or a related discipline
• 3+ years of statistical programming experience in the pharmaceutical, biotech or CRO industry
• Strong experience programming ADaM datasets and TLFs, and practical experience with SAS and R in clinical research
• Understanding of CDISC standards (ADaM, SDTM) and experience supporting regulatory submissions
• Preferred: lead programmer experience, oncology or RWE experience, knowledge of Define.xml, mentoring experience, and previous GSK or sponsor-dedicated model work

Required skills

• SAS and R programming
• CDISC ADaM and SDTM
• ICH-GCP

What we offer

• Competitive base salary and performance-related incentives
• Health, dental and vision coverage where applicable, retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities