Lead Biostatistician - Late-Phase Clinical Trials

IQVIA; Dublin; On-site; EUR 120,000 - 170,000; Full time

Job summary

IQVIA is seeking a Principal Biostatistician to lead statistical strategy and execution for late‑phase clinical trials. You will author SAPs, design analyses, and guide cross‑functional teams in regulatory‑mavorable methods.

Strong SAS and R skills, plus experience with clinical outcomes studies, are essential. The role involves cross‑functional collaboration within the Biostatistics function, providing independent statistical oversight from study design through analysis, with potential

Qualifications

• Advanced degree in Biostatistics, Statistics, or a related field (PhD preferred; Master’s accepted with significant experience).
• Proven experience working independently as a study statistician in late‑phase (Phase II/III) trials.
• Experience in pharmaceutical industry strongly preferred; CRO experience is a plus.
• Hands‑on expertise with clinical outcomes studies, including cardiovascular events, symptomatic endpoints, and quality‑of‑life measures.
• Demonstrated ability to implement complex statistical methods and guide cross‑functional teams through analytical decision‑making.
• Proficiency in SAS; working knowledge of R is advantageous.
• Experience with regulatory submissions and interaction with health authorities is a plus.

Responsibilities

• Serve as the primary statistical lead and main point of contact on the Clinical Trial Team (CTT).
• Work independently to support clinical teams, providing proactive statistical guidance throughout the study lifecycle.
• Lead statistical strategy discussions, including endpoint definitions, analysis methods, risk mitigation, and regulatory expectations.
• Independently author Statistical Analysis Plans (SAPs), including drafting with cross‑functional partners.
• Implement non‑standard or advanced statistical methodologies (e.g., time‑to‑event analyses, MMRM, estimands).
• Perform or oversee statistical analyses, ensuring scientific rigor and regulatory compliance.
• Conduct sample size calculations using SAS or R, and justify design assumptions.

Skills

Independent study statistician

Late-phase trials

Clinical outcomes analysis

Statistical methods leadership

Regulatory submissions

SAS programming

R knowledge

Cross-functional guidance

Education

Advanced degree in Biostatistics/Statistics or related field

Tools

SAS

R

CRM systems

Job description

IQVIA is seeking a Principal Biostatistician to lead statistical strategy and execution for late‑phase clinical trials. You will author SAPs, design analyses, and guide cross‑functional teams in regulatory‑mavorable methods.

Strong SAS and R skills, plus experience with clinical outcomes studies, are essential. The role involves cross‑functional collaboration within the Biostatistics function, providing independent statistical oversight from study design through analysis, with potential