Job Summary
A company is looking for a Senior Biostatistician to contribute to clinical study teams by developing statistical analyses for client-sponsored studies.
Key Responsibilities
- Lead statistician for Phase I-III clinical studies, providing statistical and programming support
- Plan and design clinical studies, including creating Statistical Analysis Plans (SAP)
- Perform quality checks on analysis datasets and reports, ensuring adherence to industry standards
Required Qualifications
- PhD or MS degree in Statistics, Biostatistics, or related field
- 5+ years of relevant work experience in the CRO, biotech, pharmaceutical, or life sciences industry
- Familiarity with clinical trial design, analysis activities, and regulatory guidelines
- Experience with NDA/BLA submission activities and statistical programs such as SAS
- Maintain awareness of industry standards, regulatory requirements, and departmental guidelines
Comments