Lead Biostatistician – Phase 1 expert – Illinois Jobs ILLINOIS
Lead Biostatistician
Knowledge, Skills and Traits:
- Excellent knowledge of Phase One in the Clinical Trials
- Thorough understanding of eCTD
- Thorough understanding of 21CFR parts 11, 54, 56, 312, and 314
- Thorough understanding of ICH guidelines
- Thorough understanding of regulatory guidances pertaining to specific indications but also to electronic submissions
- Thorough understanding of regulatory data sciences
- Thorough understanding of statistical issues in clinical trials
- Thorough understanding of issues related to adaptive trials
- Acquaintance with Bayesian statistics
- Extensive experience with SAS programming required
- Ability to work independently
- Good analytical skills
- Good project management skills
- Professional attitude
- Ability to work well with others
Communication:
- Address technical issues effectively with written and verbal communication
- Explain biostatistical and technical issues effectively to technical and non-technical staff
Education:
- Requires a Degree or equivalent in Biostatistics or a related field and at least 2 2 - 5 years experience supporting the design of clinical trials and the analysis and reporting of clinical trials data in the pharmaceutical industry.
- Experience supporting regulatory
(Real Staffing Group acts as an Employment Agency and an Employment Business)