Associate Biostatistics Director - FSP (Permanent Home-based)

IQVIA; Reading; On-site; GBP 80,000 - 120,000; Full time

Job summary

IQVIA in Reading, UK seeks a senior Biostatistician to lead statistics for a therapeutic program. You will define strategy, apply methodologies to trials and regulatory submissions, and collaborate with cross-functional teams to ensure rigorous analyses.

The role calls for strong leadership in study design, regulatory interactions, and delivery of high-quality results for internal and external stakeholders.

Qualifications

• PhD or MS in Biostatistics or related field required.
• Minimum of 8 years in clinical trial statistics, pharma/CRO preferred.
• Strong expertise in SAS/R, Bayesian methods, adaptive designs.

Responsibilities

• Lead full scope of Biostatistics conduct for the program.
• Define statistical strategy and applicable methodologies.
• Influence clinical development plans and governance reviews.
• Provide statistical partnership for Go/No Go criteria and TPS.
• Plan analyses and ensure timely interim/final results.
• Interact with regulatory authorities (FDA/EMA/PMDA).
• Interpret results and ensure reporting accuracy.
• Prepare abstracts, posters, and presentations for stakeholders.

Skills

Biostatistics leadership

Cross-functional collaboration

Statistical planning

Communication of statistics

Education

PhD or MS in Biostatistics, Statistics or related field

Tools

SAS

R

Job 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

• 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

Education

• PhD or MS in Biostatistics, Statistics or related field

Experience

• Minimum of 8 years of experience in clinical trial statistics, preferably within a pharmaceutical or CRO setting.
• Technical Expertise:
• 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
• Study Design and 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.
• Collaboration and Communication:
• 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.