Principal Scientist, Biostatistics, Late-Stage Clinical Development
$190.8k - $300.3kMerck
Principal Scientist role in Biostatistics leading late-stage clinical development projects. Provides statistical expertise for drug and vaccine development, manages cross-functional teams, and ensures compliance with regulatory requirements throughout the clinical trial lifecycle.
Responsibilities
- Lead biostatistical strategy and support for late-stage clinical drug and vaccine development projects
- Design clinical trials, develop protocols and data analysis plans, and independently apply complex statistical methodologies
- Identify potential problems in trial design and conduct; propose and implement solutions
- Lead statisticians and statistical programming staff to meet regulatory and internal standards
- Prepare reports and present clinical trial results to management, regulatory agencies, and investigators
Requirements
- PhD in statistics, biostatistics, or related field with 6+ years relevant experience, or Master's degree with 9+ years experience
- Expertise in statistical analysis methodologies and experimental design for clinical trials
- Proficiency with SAS, R, or similar statistical and data processing software
- Knowledge of worldwide regulatory requirements and phase II-V clinical trial expertise
- Strong project management and oral/written communication skills
- Demonstrated ability to work effectively in cross-functional team environments
Vacancy posted 22 days ago
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