Education requirements: 

MS or PhD in statistics or biostatistics

Years of experience:

Minimum 5 years working as a clinical trial statistician either directly for a pharmaceutical company or CRO

Key Skills:

• Consultant should have excellent working experience with study design analysis, development plan.
• This role will involve work in phase I-IV but mainly in phase I later will move to phase II & III.
• Been a Trial statistician at the study (any phase)
• Written statistical analysis plans (SAPs) including the development of mock shells.
• Reviewed CRFs
• Performed stat review for clinical trial datasets and their specification, TFLs (tables, figures, and listings), and CSRs Validated key analysis datasets and statistical outputs (TFLs)
• Performed statistical analyses and data checks using SAS
• Performed sample size calculations for studies

Programming skills:

Must know SAS well (e.g. can check accuracy of variables within datasets, perform own analyses, and check accuracy of TFLs produced by SAS programmers) Do NOT need to know how to create “pretty” outputs in SAS

Strong plus is ability to program in R (but not required)