Biostatistics Lead - Clinical Development & Submissions

Grifols; Dublin; Hybrid; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Group pension scheme

Private Medical Insurance

Career development

Succession planning

Wellness activities

Job summary

Grifols in Ireland is seeking a Biostatistician 3 to provide statistical leadership across clinical development programs. The role focuses on design, analysis, interpretation, and reporting of clinical studies to ensure robustness, regulatory compliance, and support for submissions and publications.

You will lead biostatistical activities across multiple programs, manage external partners, and collaborate with global teams to uphold standards and drive data quality across studies.

Qualifications

• PhD in Statistics, Biostatistics or related quantitative discipline with extensive clinical development experience.
• Experience in regulatory submissions and interactions with health authorities.
• Ability to lead biostatistical activities across multiple programs and manage external partners.

Responsibilities

• Serve as lead biostatistics partner to Clinical Development teams and influence trial design.
• Develop and review SAPs, CSRs, and statistical sections of protocols.
• Lead analysis, interpretation and communication of trial data and ensure regulatory compliance.
• Oversee external biostatistics resources (CROs) and ensure timely delivery.
• Represent Biostatistics in cross-functional teams and support regulatory interactions.

Skills

Clinical development

Leadership

Regulatory submissions

Study design

Data analysis

Education

PhD in Statistics/Biostatistics

MSc in related field

Tools

SAS

R

Job description

Grifols in Ireland is seeking a Biostatistician 3 to provide statistical leadership across clinical development programs. The role focuses on design, analysis, interpretation, and reporting of clinical studies to ensure robustness, regulatory compliance, and support for submissions and publications.

You will lead biostatistical activities across multiple programs, manage external partners, and collaborate with global teams to uphold standards and drive data quality across studies.