
Lead Clinical Statistician
10 hours ago
Job Title: Senior Biostatistician
Job DescriptionThe Senior Biostatistician plays a key role in leading, developing, implementing, and overseeing statistical strategies and deliverables in support of clinical trials. Under the guidance of Head of Biostatistics, this role contributes to planning, execution, and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.
This individual serves as biostatistics leader for assigned studies and projects, leads or contributes to study design discussions, including protocol development, endpoint definition, and sample size estimation. They oversee and ensure the execution of statistical analyses per Statistical Analysis Plan (SAP) in collaboration with programming and CRO partners.
The Senior Biostatistician provides statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables. They regularly communicate project status to management and escalate issues or risks in a timely manner. This role also involves providing statistical input and review for clinical study reports, regulatory documents, and publications.
Key Responsibilities:
- Biostatistics leadership for assigned studies and projects
- Study design discussions, including protocol development, endpoint definition, and sample size estimation
- Author and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings (TFLs)
- Oversee and ensure the execution of statistical analyses per SAP
- Vendor oversight, including directing statistical programming activities and managing deliverables
- Regular communication of project status to management
- Statistical input and review for clinical study reports, regulatory documents, and publications
To be successful in this role, you should possess the following skills and qualifications:
- Master's degree or PhD in Biostatistics, Statistics, or related quantitative field
- Minimum of 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum of 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 (e.g., SDTM, ADaM) and their application
- Experience with regulatory support and interaction
- Experience providing statistical oversight of vendors and managing CRO collaborations
This role offers the opportunity to work on challenging projects, collaborate with cross-functional teams, and contribute to the development of cutting-edge statistical methods and tools.
OthersYou will have the chance to stay current with emerging statistical methodologies and evolving clinical trial practices, and perform other duties/tasks as required or assigned.
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