Principal Biostatistician, FSP

🔥 15 minutes ago

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

💰 $1G Post-IPO Debt on 2023-05

Healthcare Insurance • Biotechnology • Artificial Intelligence

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

• Serve as the primary statistical lead and main point of contact on the Clinical Trial Team (CTT) • Work independently to support clinical teams, providing proactive statistical guidance throughout the study lifecycle • Lead statistical strategy discussions, including endpoint definitions, analysis methods, risk mitigation, and regulatory expectations • Independently author Statistical Analysis Plans (SAPs) • Implement non-standard or advanced statistical methodologies • Perform or oversee statistical analyses, ensuring scientific rigor and regulatory compliance • Conduct sample size calculations using SAS or R • Work closely with statistical programmers • Actively participate in CTT meetings, offering statistical expertise

🎯 Requirements

• Advanced degree in Biostatistics, Statistics, or a related field (PhD preferred; Master’s accepted with significant experience) • Proven experience working independently as a study statistician in late-phase (Phase II/III) clinical trials • Experience in pharmaceutical industry strongly preferred; CRO experience is a plus • Hands-on expertise with clinical outcomes studies, including cardiovascular events, symptomatic endpoints, and quality-of-life measures • Demonstrated ability to implement complex statistical methods and guide cross-functional teams through analytical decision-making • Proficiency in SAS; working knowledge of R is advantageous • Experience with regulatory submissions and interaction with health authorities is a plus.

🏖️ Benefits

• Medical benefits • Dental benefits • 401(k) retirement plan • Flexible work arrangements • Professional development opportunities