Senior Biostatistician – Vaccines

ICON plc

full-time

Posted on: 9/4/2025

Location: 🇺🇸 United States

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Senior

About the role

Provide scientifically rigorous statistical input on post-hoc / ad-hoc analysis requests in supporting publication projects and regulatory query responses
Develop statistical analysis plan, mock-up tables, quality check plan
Oversee programming support activities for assigned projects
Validate the accuracy, consistency and integrity of the statistical output displays generated by programmers
Lead multiple project teams by applying project management skills, statistical and programming techniques to prepare, execute, report, and document of high-quality statistical analysis per statistical analysis plans
Conduct peer review of project related work performed by other statisticians, maintain compliance with the latest regulatory requirements, maintain project documentation and files according to departmental policy
Communicate competently and independently with client to coordinate the statistical and programming considerations of the project
Demonstrate strong understanding of ICH guidelines and clinical trial design, as applicable to statistics

Masters in Statistics/Biostatistics (or related field) with 8+ years’ experience in clinical trials, or PhD in Statistics/Biostatistics (or related field) with 4+ years’ experience in clinical trials
Effective verbal and written communication skills
Understanding of broad statistical theory and its application
Able to fully understand clinical questions and concepts and to translate and simplify them into SAP development followed by data generation all the way through publication
Effective at clearly explaining statistical concepts to colleagues without statistical training
Work collaboratively as a team member
Experience with statistical modelling of clinical data and statistical inference
Experience in R or SAS programming languages