Senior Statistical Programmer

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Develop, validate, and sustain ADaM datasets in accordance with CDISC standards and regulatory requirements (FDA, PMDA, EMA).

• Design and produce Tables, Listings, and Figures (TLFs) to assist clinical study reports (CSRs).

• Work collaboratively with statisticians, data managers, and clinical teams to understand analysis needs.

• Create and update ADaM specifications (define.xml, metadata, reviewers guides).

• Conduct quality control (QC) and validation of statistical programming outputs.

• Ensure adherence to company SOPs, industry best practices, and regulatory guidelines.

• Engage in study start-up tasks, including CRF annotation and derivation specifications.

• Resolve programming challenges and suggest effective solutions.

• Assist in regulatory submissions and address health authority inquiries as required.

• Contribute to ongoing process enhancement and standardization initiatives.

⛳️ Requirements

• Bachelor's degree in statistics, computer science, mathematics, or a related field.

• Extensive experience in statistical programming within the clinical research or pharmaceutical sector.

• Strong expertise in CDISC programming with a comprehensive understanding of statistical concepts and methodologies.

• Exceptional analytical skills, meticulous attention to detail, and the capability to manage multiple projects concurrently.

• Strong communication and interpersonal abilities, with a talent for collaborative work within a multidisciplinary team.

• Employment with ICON requires having the legal right to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary and performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Learning and development opportunities through structured training and career pathways.