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