Senior Statistical Programmer – FSP

🔥 0 minutes ago

🌐 Germany, France, +10 more countries – Remote

🇩🇪 Germany – Remote 🇫🇷 France – Remote 🇦🇹 Austria – Remote 🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇷🇴 Romania – Remote 🇮🇹 Italy – Remote 🇵🇹 Portugal – Remote 🇫🇮 Finland – Remote 🇭🇷 Croatia – Remote 🇬🇷 Greece – Remote 🇩🇰 Denmark – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Lead and contribute to statistical programming activities across Phase I-IV clinical trials • Develop, validate, and maintain analysis datasets, tables, listings, figures (TLFs), and other study deliverables using SAS and R • Support efficacy and safety analyses in accordance with CDISC standards and study requirements • Author and review programming specifications and related documentation • Perform quality control and validation of programming outputs • Support regulatory submissions and ensure compliance with global regulatory standards • Collaborate with Biostatistics, Data Management, and cross-functional study teams • Act as a Lead Programmer or Study Lead, providing oversight and technical guidance as required

🎯 Requirements

• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field • Minimum 5 years of statistical programming experience within the pharmaceutical, biotechnology, or CRO industry • Strong programming experience with SAS (Base and Macro) and R • Strong knowledge of CDISC standards, including SDTM, ADaM, and Pinnacle 21 • Proven experience supporting efficacy analyses and statistical reporting for clinical trials • Experience developing and reviewing ADaM specifications and regulatory deliverables • Strong understanding of clinical trial statistical methods, TLFs, and graphical outputs • Experience serving as a Study Lead or Lead Programmer on global clinical studies • Working knowledge of clinical trial data, including efficacy, safety, and PK/PD • Preferred: Hands-on experience with R programming in a clinical research environment • Preferred: Experience supporting global regulatory submissions (FDA, EMA, PMDA) • Preferred: Previous experience working within an FSP model supporting pharmaceutical sponsors

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