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1 day ago
The Senior Biostatistics Expert plays a key role in leading and developing statistical strategies for clinical trials, collaborating with cross-functional teams to ensure high-quality deliverables.
- Leadership Role: Serve as biostatistics leader for assigned studies and projects, guiding the development of statistical analysis plans (SAPs) and ensuring timely execution of statistical analyses.
- Study Design: Contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation, utilizing expertise in statistical methodologies and clinical trial designs.
- Statistical Expertise: Author and review SAPs, providing statistical leadership in vendor oversight, managing deliverables, and performing quality control (QC) of statistical outputs.
- Communication: Regularly communicate project status to management, escalating issues or risks in a timely manner, and delivering statistical presentations to internal and external stakeholders.
- Education: Master's degree or PhD in Biostatistics, Statistics, or related quantitative field is required.
- Experience: A minimum of 8 years of experience in clinical trial biostatistics for MS-level candidates; a minimum of 6 years for PhD-level candidates.
- Skills: Proficiency in statistical programming in SAS, knowledge of R and other programming languages preferred, solid knowledge of CDISC standards, and excellent verbal and written communication skills are essential.
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