
Principal Quantitative Analyst
2 days ago
Job Summary:
The Senior Biostatistician will lead statistical strategies and deliverables in support of clinical trials. This role contributes to planning, execution, and interpretation of statistical analyses across development programs.
Key Responsibilities:
- Oversee biostatistics efforts for assigned studies and projects.
- Contribute to study design discussions, including protocol development and endpoint definition.
- Author and review Statistical Analysis Plans (SAPs) and ensure execution of statistical analyses per SAP.
- Provide statistical leadership in vendor oversight and manage deliverables.
- Regularly communicate project status and escalate issues or risks.
- Provide statistical input and review for clinical study reports and publications.
- Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards.
Requirements:
- Masters degree or PhD in Biostatistics, Statistics, or related quantitative field.
- Minimum of 8 years of experience in clinical trial biostatistics.
- Proficiency in statistical programming in SAS and knowledge of R and other programming languages.
- Solid knowledge of statistical methodologies and clinical trial designs.
- Strong understanding of CDISC standards and their application.
Skills and Abilities:
- Excellent verbal and written communication skills.
- Ability to explain statistical concepts to non-statisticians.
- Proven ability to manage multiple studies and timelines concurrently.
- Ability to work as a team and convince your position within cross-functional teams.
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