Senior Principal Biostatistician

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

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

Position Summary:

As a Biostatistician 3, you will provide statistical leadership across clinical development programs, overseeing the design, analysis, interpretation, and reporting of clinical studies. You will ensure that all statistical deliverables are scientifically robust, regulatory compliant, and support successful clinical development, regulatory submissions, and publications.

What You Will Do:

• Serve as the lead biostatistics partner to Clinical Development teams, providing expert input into clinical trial design, methodology, and study execution.
• Develop and review statistical sections of clinical trial protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs).
• Lead the analysis, interpretation, validation, and communication of clinical trial data and study results.
• Ensure the quality, accuracy, and scientific integrity of all statistical deliverables in line with global regulatory requirements and industry standards.
• Oversee and manage external biostatistics resources, including Contract Research Organizations (CROs) and consultants, ensuring high-quality and timely delivery of work.
• Review key data management and statistical programming documentation to ensure compliance with regulatory expectations and data quality standards.
• Lead blinded data review meetings and provide statistical oversight throughout study conduct.
• Oversee randomization strategy development and randomization schedule generation.
• Contribute to the development and continuous improvement of statistical processes, methodologies, standards, and Standard Operating Procedures (SOPs).
• Represent Biostatistics in cross-functional teams and support interactions with global regulatory authorities, including FDA and other health agencies.
• Provide statistical expertise for regulatory submissions, health authority meetings, and responses to regulatory questions.

What You Will Bring:

PhD in Statistics, Biostatistics, or a related quantitative discipline with a minimum of 8 years' experience in clinical development within the pharmaceutical or biotechnology industry; alternatively, an MSc with a minimum of 10 years' relevant industry experience.

Extensive experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry.

Strong knowledge of clinical trial design, statistical methodologies, and regulatory requirements.

Experience supporting regulatory submissions and interactions with global health authorities.

Ability to communicate complex statistical concepts clearly to both technical and non-technical stakeholders.

Proven experience leading biostatistical activities across multiple clinical development programs and managing external partners.

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Wellness activities - Social activities eg. Padel, Summer Events