Associate Biostatistics Director – FSP

🕒 April 29

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

👔 Director

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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

• Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area • Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions • Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews • Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents • Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations • Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions • Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA) • Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents • Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge

🎯 Requirements

• PhD or MS in Biostatistics, Statistics or related field • Minimum of 8 years of experience in clinical trial statistics, preferably within a pharmaceutical or CRO setting • Advanced proficiency in SAS / R for data analysis and statistical programming • Experience with Bayesian methods, predictive modeling, and simulation techniques • Proven track record in strategic study design, including adaptive designs, sample size calculations, and interim analysis planning • Familiarity with regulatory guidance on statistical methodologies (e.g., FDA, EMA, PMDA) • Solid experience in applications of advanced statistical methodologies • Leading roles in regulatory submissions • Experience in interactions with major regulatory authorities preferred

🏖️ Benefits

• Flexible working hours • Professional development opportunities