We are currently hiring a Biostatistician to join our FSP Team! This individual will provide statistical support for projects in the Vaccines Therapeutic Area. The successful candidate will collaborate and work closely with project / study teams and provide statistical expertise in designing research concepts, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, writing/reviewing reports, and publishing manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. In this role you will; Provide scientifically rigorous statistical input on post-hoc / ad-hoc analysis requests in supporting publication projects and regulatory query responses.
Develop statistical analysis plans, mock-up tables, quality check plans.
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.
You will have; 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
Experience with statistical modelling of clinical data and statistical inference
Experience in R or SAS programming languages
Experience with different study designs, protocol development, and statistical analysis plan writing
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