Job Summary
A contract research organization and statistical software developer is seeking a Telecommute Rare Diseases and Clinical Trials Principal Biostatistician.
Core Responsibilities Include:
- Providing statistical leadership and statistical expertise into clinical development plans
- Providing oversight of statistical analysis plans, statistical outputs, and other documents
- Providing statistical output as required for manuscripts
Skills and Requirements Include:
- Master's degree in Statistics, Biostatistics or related discipline
- 5-10 year's experience in statistical or biostatistical analysis
- Knowledge of international regulatory guidelines applicable to clinical development
- Some experience of regulatory interactions and data submission to FDA
- Working SAS & CDISC knowledge
