Principal Biostatistician - Early Phase

July 24

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

💵 $122.8k - $233.4k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

🦅 H1B Visa Sponsor

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IQVIA

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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.

10,000+ employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

💰 $1G Post-IPO Debt on 2023-05

📋 Description

• The Principal Biostatistician is responsible for providing statistical support for drug development programs in early phases.

🎯 Requirements

• Collaborate with multi-disciplinary project teams to establish project timelines. • Provide statistical input to study protocols. • Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts. • Write statistical analysis plans. • Monitor internal and CRO project activities including timelines, deliverables, and availability of resources. • Collaborates with Data Management, Clinical Development, and Clinical Operations with statistical expertise. • Contributes to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc. • Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures. • Interpret study results and review reports of study results for accuracy. • Participate and contribute to authoring of Clinical Development Plan. • Support exploratory analyses and medical affairs publications. • Participate in pre-IND and NDA activities. • Participates in other activities and meetings to support Biostatistics and the Development Team as needed.

🏖️ Benefits

• Home-based remote working opportunities • Work/life balance as well as flexible schedules • Collaborating with motivated, high-performance, statistical and research teams • Technical training and tailored development curriculum • Research opportunities that match your unique skillset • Promising career trajectory • Job stability: long-term engagements and re-deployment opportunities • Focus on bringing new therapies to market rather than project budgets and change orders. • Experience with regulatory submissions. • Engaging, fast-paced environment. • Good work-life balance.