Senior Principal Statistician (AD) - UK & Europe

Senior Principal Biostatistician (Associate Director)
Location: UK / Mainland Europe


Overview:
We are seeking an experienced Senior Principal Biostatistician (Associate Director) to join our client’s team at a leading Contract Research Organization, working at project lead level. This is a key role focused on providing statistical leadership for clinical studies, ensuring rigorous methodologies, data integrity, and regulatory compliance throughout the clinical development process. While there is no direct line management responsibility, this position requires extensive collaboration across multidisciplinary teams and offers the opportunity to mentor junior statisticians.

Key Responsibilities:

• Statistical Leadership: Lead the design and implementation of statistical analysis plans (SAPs) for clinical trials, ensuring alignment with study objectives, regulatory guidelines, and industry best practices.
• Data Analysis & Interpretation: Oversee the statistical analysis of clinical trial data, offering expert insights and interpretations that support informed decision-making and reporting.
• Cross-functional Collaboration: Work closely with cross-functional teams including clinical, regulatory, data management, and medical affairs to ensure integrated study design, execution, and delivery of results.
• Regulatory & Publication Support: Contribute to the preparation of regulatory submissions (e.g., INDs, NDAs) and clinical trial publications, ensuring statistical rigor, transparency, and adherence to industry standards.
• Study Design Contributions: Provide input into clinical study protocols, with a focus on statistical considerations for endpoints, design strategies, and analysis approaches.
• Mentorship & Training: Mentor junior statisticians and support their development by providing guidance and training on statistical methodologies and software applications.
• Innovation & Best Practices: Stay up to date with the latest advancements in biostatistics and clinical trial methodology. Drive innovation in statistical approaches, optimizing study design and analysis processes.

• Educational Background: A Master’s degree or Ph.D. in Biostatistics, Statistics, or a related field is required.
• Experience: Extensive experience in biostatistics, specifically in clinical trial design and analysis, within the pharmaceutical, biotechnology, or contract research organization sectors.
• Technical Skills: Strong proficiency in statistical software (e.g., SAS, R) and advanced programming skills for data manipulation and analysis.
• Leadership: Demonstrated experience in providing statistical leadership, particularly in mentoring junior staff and leading statistical contributions in clinical trials.
• Problem-Solving & Communication: Strong analytical problem-solving skills with the ability to interpret complex statistical data and clearly communicate findings to non-statistical stakeholders.
• Organizational Skills: Excellent attention to detail with the ability to manage multiple projects simultaneously, ensuring high-quality deliverables on time within a fast-paced, deadline-driven environment.
• Regulatory Knowledge: Familiarity with global regulatory requirements and guidelines (e.g., ICH E9, FDA, EMA) relevant to clinical trials and statistical methodologies.

Interested? Please get in touch with me directly: - aimee@warmanobrien.com