Strategic Lead Biostatistician for Regulatory Submissions

IQVIA; Dublin; On-site; EUR 80,000 - 100,000; Full time

Job summary

A leading global clinical research organization is seeking a Principal Biostatistician in Dublin. The ideal candidate will lead statistical planning and analysis for clinical trials, ensuring compliance with regulatory standards. Responsibilities include developing protocols, analyzing data, and interacting with regulatory agencies. Applicants should possess a Masters or PhD in Biostatistics or a related field and strong experience with SAS or R.

Qualifications

• Experience in Phase 2-3 clinical trials required.
• Expertise in statistical methods and regulatory submissions.
• Proven collaboration with clinical and development teams.

Responsibilities

• Lead the quality planning, analysis, and reporting for clinical trials.
• Serve as biostatistical consultant and attend regulatory meetings.
• Develop/review protocols and analysis plans for major projects.

Skills

Statistical analysis

Statistical methodology

Regulatory compliance

SAS

R

CDISC Data Standards

Communication skills

Problem solving

Education

Masters or PhD in Biostatistics or related field

Tools

SAS

R

Job description

A leading global clinical research organization is seeking a Principal Biostatistician in Dublin. The ideal candidate will lead statistical planning and analysis for clinical trials, ensuring compliance with regulatory standards. Responsibilities include developing protocols, analyzing data, and interacting with regulatory agencies. Applicants should possess a Masters or PhD in Biostatistics or a related field and strong experience with SAS or R.