Senior Biostatistician – Vaccines
ICON plc
Job Level
Lead
About the role
- 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.
Requirements
- 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.
- Strong computational skills.
- Experience with various study designs, protocol development, and statistical analysis plan writing.
