Statistical Programmer II

🔥 0 minutes ago

🌐 United Kingdom, France, +4 more countries – Remote

🇬🇧 United Kingdom – Remote 🇫🇷 France – Remote 🇩🇪 Germany – Remote 🇵🇱 Poland – Remote 🇮🇪 Ireland – Remote 🇿🇦 South Africa – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥 Software Engineer

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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 and quality control NONMEM PK/PD datasets using SDTM and ADaM data sources • Support pharmacometric modelling activities by delivering accurate, complete, and submission-ready datasets • Perform quality review of internally and externally produced NONMEM datasets • Collaborate with Data Management, Statistical Programming, Statistics, Clinical Pharmacology, and Bioanalytical teams to resolve data issues and meet project timelines • Contribute to regulatory submission projects in accordance with internal pharmacometrics guidelines • Conduct quality control testing of customised R packages used to standardise pharmacometric workflows • Develop and maintain testing frameworks and validation processes for departmental R tools and packages • Identify data discrepancies, process improvements, and opportunities for automation and efficiency • Contribute to new pharmacometric standardisation initiatives • Ensure deliverables comply with SOPs, working instructions, regulatory requirements, and ICH-GCP guidelines • Maintain inspection readiness through ongoing training and adherence to quality standards

🎯 Requirements

• Bachelor's degree in a Life Science, Health Science, Statistics, Computer Science, IT, or related discipline • Minimum of 6 years' experience within the pharmaceutical, biotechnology, or CRO industry • Strong programming expertise in R • Experience developing and quality controlling NONMEM PK/PD datasets • Working knowledge of PK/PD principles and pharmacometric workflows • Strong understanding of SDTM, ADaM, and CDISC standards, including controlled terminology • Experience supporting NONMEM file creation, quality control, submissions, and standardisation activities • Strong attention to detail and commitment to data quality • Excellent written and verbal communication skills in English • Experience reviewing and managing outsourced programming deliverables • Experience validating or quality controlling customised R packages • Demonstrated ability to identify process improvements and drive standardisation initiatives • Ability to work effectively across global, cross-functional teams • 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 • Collaborative environment • Stability and career development • Opportunity to work within a globally recognised Clinical Pharmacology & Pharmacometrics function • Contribution to innovative drug development programmes • Ongoing innovation and standardisation initiatives within pharmacometrics and clinical data science