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
