Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Senior Biostatistician providing statistical contributions and leading strategies for clinical trials and regulatory submissions. Ensuring quality deliverables and interacting with regulatory authorities.
Responsibilities
- Provide statistical contributions to a clinical development program
- Implement statistical strategies for clinical trials and regulatory submissions
- Ensure the timely completion and quality of the Statistical Analysis Plan (SAP)
- Support Biostatistics interactions with regulatory authorities (e.g., FDA, EMA, PMDA)
- Interpret analysis results and ensure accuracy and clarity of reporting
- Manage outsourced statistical activities or collaborate with internal statistical programmers
Requirements
- PhD or MS in Biostatistics, Statistics, or a related field
- PhD with at least 3 years of experience in drug development, or MS with at least 6 years of experience in drug development
- Advanced knowledge of statistical methodologies in clinical development
- Strong interpersonal and communication skills (written and verbal in English)
- Proficiency in SAS and/or R
- Familiarity with relevant regulatory guidance documents
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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