Senior Statistical Programmer

🔥 4 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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.

🎯 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. • Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

🏖️ 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