Job Summary
A statistical software developer has a current position open for a Remote Biostatistics Associate Director.
Must be able to:
- Present and explain methodology and consequences of decisions in lay terms
- Prepare clinical study reports, including integrated summaries for submissions (ISS/ISE);
- Review CRFs and data review guidelines while developing statistical analysis plans
Must meet the following requirements for consideration:
- Master’s degree in statistics or a related discipline. PhD strongly desired
- Experience in Early Development studies desirable
- Knowledge and implementation of advanced statistical methods
- Adept in ADaM specifications generation and programmatic review of datasets
- Ability to be flexible when priorities change and deal with ambiguity
- Solid understanding & implementation of CDISC requirement for regulatory submissions
