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2 days ago
Job Title: Senior Biostatistician
">Key Responsibilities:
- Lead biostatistical efforts for assigned studies and projects, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.
- Collaborate with cross-functional teams to design studies, including protocol development, endpoint definition, and sample size estimation.
- Develop and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings (TFLs).
- Oversee statistical programming activities, manage vendor partnerships, and ensure compliance with internal standards.
- Communicate project status to management and escalate issues or risks in a timely manner.
- Contribute to the development of clinical study reports, regulatory documents, and publications.
- Maintain current knowledge of emerging statistical methodologies and evolving clinical trial practices.
Requirements:
- Master's degree or PhD in Biostatistics, Statistics, or related quantitative field.
- Minimum 8 years of experience in clinical trial biostatistics; strong understanding of CDISC standards.
- Proficiency in statistical programming in SAS, R, and other programming languages.
- Excellent verbal and written communication skills, with ability to explain statistical concepts to non-statisticians.
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