Job Summary
A contract research organization is searching for a person to fill their position for a Telecommute Principal or Senior Biostatistician.
Core Responsibilities Include:
- Supporting large Pharma and Biotech clients in clinical trials
- Anticipating issues and providing solutions or options to those issues
- Taking leadership and responsibility of own projects
Must meet the following requirements for consideration:
- MS or PhD in statistics or biostatistics
- Minimum 5 years working as a clinical trial statistician either directly for a pharmaceutical company or CRO
- Reviewed CRFs and validated key analysis datasets and statistical outputs (TFLs)
- Performed stat review for clinical trial datasets and their specification, TFLs (tables, figures, and listings), and CSRs
- Performed statistical analyses and data checks using SAS and performed sample size calculations for studies
- 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)
- Written statistical analysis plans (SAPs) including the development of mock shells
- Been a lead statistician at the study (any phase)