Senior Principal Biostatistician
Home Office, IE
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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. |
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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:
- 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:
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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.
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Extensive experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry.
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Strong knowledge of clinical trial design, statistical methodologies, and regulatory requirements.
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Experience supporting regulatory submissions and interactions with global health authorities.
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Ability to communicate complex statistical concepts clearly to both technical and non-technical stakeholders.
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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
- Education allowance
- Wellness activities - Social activities eg. Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you
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Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3