Director, Global Biostatistics & Clinical Strategy

IQVIA; Dublin; On-site; EUR 110,000 - 180,000; Full time

Job summary

IQVIA is seeking a Lead Biostatistician to supervise the full scope of biostatistics for a therapeutic program, ensuring robust statistical strategy and regulatory-ready analyses for trials and submissions.

The role requires leading statistical planning, collaborating with cross-functional teams, and communicating complex results to stakeholders. Minimum 8 years in clinical trial statistics, PhD/MS in Biostatistics, and strong SAS/R skills are essential. Dublin, Ireland based, with global impact.

Qualifications

• PhD or MS in Biostatistics, Statistics or related field.
• Minimum of 8 years of experience in clinical trial statistics, preferable within a pharmaceutical or CRO setting.
• Proficiency in SAS / R and familiarity with regulatory guidance.

Responsibilities

• 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

Skills

SAS/R

Bayesian methods

Predictive modeling

Simulation techniques

Adaptive design

Go/No-Go criteria

Regulatory submissions

Statistical leadership

Regulatory communications

Education

PhD or MS in Biostatistics

Tools

SAS

R programming

Job description

IQVIA is seeking a Lead Biostatistician to supervise the full scope of biostatistics for a therapeutic program, ensuring robust statistical strategy and regulatory-ready analyses for trials and submissions.

The role requires leading statistical planning, collaborating with cross-functional teams, and communicating complex results to stakeholders. Minimum 8 years in clinical trial statistics, PhD/MS in Biostatistics, and strong SAS/R skills are essential. Dublin, Ireland based, with global impact.