Principal Biostatistician, FSP – Permanent Homebased

🕒 July 28

🌐 Germany, Sweden, +5 more countries – Remote

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⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 33%

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Logo of IQVIA

IQVIA

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

• Serve as the primary statistical lead and main point of contact on the Clinical Trial Team • Provide proactive statistical guidance throughout the clinical study lifecycle • Lead statistical strategy discussions covering endpoint definitions, analysis methods, risk mitigation, and regulatory expectations • Author Statistical Analysis Plans in collaboration with cross-functional partners, pharma statisticians, or from finalized protocols • Implement non-standard and advanced statistical methodologies • Perform or oversee statistical analyses while ensuring scientific rigor and regulatory compliance • Conduct sample size calculations and justify design assumptions to clinical leadership • Direct statistical programmers, review outputs, and align SAP and programming deliverables • Contribute hands-on with SAS programming and clinical dataset analyses when needed • Participate in Clinical Trial Team meetings and drive alignment across clinical, programming, data management, and medical writing partners • Communicate statistical concepts clearly to non-statistical stakeholders • Represent Biostatistics within cross-functional teams and provide scientific oversight and strategic guidance across late-phase clinical trials

🎯 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 • Ability to work independently and represent Biostatistics within cross-functional teams • Ability to author Statistical Analysis Plans (SAPs) • Experience with complex time-to-event analyses, MMRM and other longitudinal models, and estimand-aligned methods • Experience conducting sample size calculations using SAS or R • Experience collaborating with statistical programmers and reviewing programming outputs

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