Senior Principal Biostatistician

This is a fully remote position, open to applicants in Ireland.

📋 Description

• Act as the primary biostatistics collaborator for Clinical Development teams, offering expert guidance on clinical trial design, methodology, and execution.

• Create and evaluate statistical components of clinical trial protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs).

• Drive the analysis, interpretation, validation, and communication of clinical trial data and outcomes.

• Ensure the quality, precision, and scientific validity of all statistical outputs in accordance with global regulatory standards and industry practices.

• Supervise and coordinate external biostatistics resources, such as Contract Research Organizations (CROs) and consultants, guaranteeing high-quality and timely project delivery.

• Review essential data management and statistical programming documents to ensure adherence to regulatory standards and data quality metrics.

• Lead blinded data review meetings and offer statistical oversight throughout the study execution process.

• Manage the development of randomization strategies and the generation of randomization schedules.

• Contribute to the enhancement and ongoing refinement of statistical processes, methodologies, standards, and Standard Operating Procedures (SOPs).

• Represent the Biostatistics team in cross-functional collaborations and facilitate interactions with global regulatory bodies, including the FDA and other health authorities.

• Provide statistical expertise for regulatory submissions, meetings with health authorities, and responses to regulatory inquiries.

⛳️ Requirements

• PhD in Statistics, Biostatistics, or a related quantitative field with at least 8 years of experience in clinical development within the pharmaceutical or biotechnology sectors; or an MSc with a minimum of 10 years of relevant industry experience.

• Comprehensive experience in biostatistics within the pharmaceutical, biotechnology, or clinical research sectors.

• In-depth knowledge of clinical trial design, statistical methodologies, and regulatory frameworks.

• Experience in supporting regulatory submissions and engaging with global health authorities.

• Capability to articulate complex statistical concepts clearly to both technical and non-technical audiences.

• Demonstrated experience leading biostatistical initiatives across various clinical development programs and managing external collaborators.

🏝️ Benefits

• Highly competitive salary.

• Group pension scheme - Contribution rates are (1.5% / 3% / 5% / 7%) with company matching.

• Private Medical Insurance for the employee.

• Continuous career development opportunities in a rapidly growing work environment.

• Succession planning and opportunities for internal promotions.

• Education allowance.

• Wellness initiatives - Social activities such as Padel and Summer Events.