Associate Biostatistics Director - FSP (Permanent Home-based)

IQVIA; Badminton; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading global clinical research provider is seeking a Biostatistics lead in Badminton, UK. The ideal candidate will have over 8 years of experience in clinical trial statistics and will oversee statistical strategy for clinical development. Responsibilities include collaborating with teams for trial designs and ensuring compliance with regulatory requirements. Strong proficiency in SAS and R is a must, along with excellent communication skills to present findings effectively. This role plays a crucial part in improving patient outcomes through innovative medical treatments.

Qualifications

• Minimum of 8 years of experience in clinical trial statistics.
• Proven track record in strategic study design.
• Strong communication skills to present statistical concepts.

Responsibilities

• Lead full scope of Biostatistics conduct for clinical trials.
• Collaborate with cross-functional teams for governance reviews.
• Provide statistical thought partnership for innovative study design.
• Represent Biostatistics in interactions with regulatory authorities.
• Prepare reports and presentations to communicate clinical results.

Skills

Clinical trial statistics

Statistical strategy development

Advanced proficiency in SAS / R

Bayesian methods

Predictive modeling

Regulatory submissions

Complex study designs

Communication skills

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

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