Senior Statistician

• Educated to the MSc level (or equivalent) in statistics or a related discipline.
• 3+ years of prior Lead Statistician experience within clinical research.
• Excellent knowledge and understanding of the statistical principles, concepts, methods and standards used in clinical research.
• Communicate with project teams, clients and vendors on statistical questions.

RESPONSIBILITIES

• Develop and manage biometrics documentation, including Statistical Analysis Plans (SAP), Randomisation Specifications, and Statistical Reports.
• Provide input into the Protocol, Clinical Study Report (CSR), Study Design, and Sample Size Calculations as required.
• Communicate and discuss complex statistical methods and approaches with the client and wider study team.
• SAS programming and program validation.

Desired Skills/Experience

• An advanced working knowledge of statistical applications, which may include (but not limited to) SAS, R, Multiple Imputation, Mixed Models, Estimands Framework.
• Experience working on Phase I- IV study trials within clinical research.
• An awareness of CDISC standards and FDA guidelines.