Principal Biostatistician – Vaccines Therapeutic Area

We are seeking a highly skilled FSP Statistician to support projects in the Vaccines Therapeutic Area within Research and Development. The successful candidate will collaborate closely with project and study teams, providing statistical expertise in designing research concepts, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, reviewing reports, and co-authoring manuscripts for publication. This role may also involve supporting regulatory submissions and responding to regulatory queries. Ideal candidates will demonstrate strong quantitative and creative thinking and stay current with developments in statistical methodologies.

Responsibilities & Duties

• Provide scientifically rigorous statistical input on post-hoc and ad-hoc analysis requests to support publication projects and regulatory query responses.
• Develop statistical analysis plans, mock-up tables, and quality check plans.
• Oversee programming support activities for assigned projects and validate the accuracy, consistency, and integrity of statistical output displays generated by programmers.
• Lead multiple project teams using project management skills and statistical/programming techniques to prepare, execute, report, and document high-quality statistical analyses.
• Conduct peer reviews of project-related work performed by other statisticians, ensure compliance with regulatory requirements, and maintain project documentation and files.
• Communicate effectively and independently with the client to coordinate statistical and programming aspects of the project.
• Demonstrate a strong understanding of ICH guidelines and clinical trial design as applicable to statistics.

Basic Qualifications

• Master’s degree in Statistics/Biostatistics with 8+ years of experience in clinical trials, or PhD in Statistics/Biostatistics with 4+ years of experience.
• Effective verbal and written communication skills.
• Understanding of broad statistical theory and its application.
• Ability to understand clinical questions and concepts and translate them into SAP development, followed by data generation and publication.
• Ability to clearly explain statistical concepts to colleagues without statistical training.
• Strong team collaboration skills.
• Experience with statistical modeling of clinical data and statistical inference.
• Proficiency in R or SAS programming languages.
• Located in a time zone within the United States or Europe (UTC-8 to UTC+2) to support real-time collaboration.

Preferred Qualifications

• Strong computational skills.
• Experience with various study designs, protocol development, and statistical analysis plan writing.