Associate Biostatistics Director – FSP

🕒 July 28

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

👔 Director

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 33%

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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 full scope of Biostatistics conduct for the responsible program within a therapeutic area • Define statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions • Influence and contribute to clinical development plans • Collaborate with cross-functional teams for governance reviews • Lead statistical strategy for planning and study execution as a member of the Study Executive Team and Clinical Development Team • Provide quantitative evaluation for 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 project-wide planning of analyses and ensure quality and timely delivery of interim and final results, including integrated analyses for submissions • Represent Biostatistics in interactions with regulatory authorities, including FDA, EMA, and PMDA • Interpret analysis results and ensure reporting accuracy in study reports and regulatory documents • Prepare abstracts, posters, oral presentations, and written reports communicating clinical program and study results to internal and external stakeholders

🎯 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 • Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy • Ability to lead statistical discussions during protocol development and study planning • Skilled in defining statistical analysis plans (SAP) and developing strategic approaches for complex study designs • Experience in strategy discussions involving adaptive design, go/no-go criteria, and futility analyses • Strong communication skills to effectively present statistical concepts to cross-functional teams • Proven experience in collaborating with clinical and regulatory teams to align statistical strategy with overall program objectives