
Clinical Trials Lead Statistician
1 day ago
This role involves leading and overseeing statistical strategies and deliverables for clinical trials, ensuring high-quality, timely results that meet regulatory and scientific standards.
Key Responsibilities:- Lead biostatistics efforts for assigned studies and projects, contributing to planning, execution, and interpretation of statistical analyses.
- Collaborate in study design discussions, including protocol development, endpoint definition, and sample size estimation, as well as reviewing Statistical Analysis Plans (SAPs).
- Oversee the execution of statistical analyses per SAP with programming and CRO partners, providing statistical leadership in vendor oversight.
- Communicate project status to management and escalate issues or risks as needed, delivering statistical presentations to internal and external stakeholders.
- Provide statistical input and review for clinical study reports, regulatory documents, and publications, performing quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards.
- Masters degree or PhD in Biostatistics, Statistics or related quantitative field, required. Minimum 8 years experience in clinical trial biostatistics for MS-level candidates; minimum 6 years for PhD-level candidates.
- Proficiency in statistical programming in SAS, knowledge of R and other programming languages is preferred.
- Solid knowledge of statistical methodologies and clinical trial designs, strong understanding of CDISC standards and their application.
- Experience providing statistical oversight of vendors and managing CRO collaborations.
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