Overview
As Principal Biostatistician, you drive statistical leadership across studies, mentoring the biostatistics team and shaping project analyses. You oversee SAPs, data handling, and reporting, while ensuring regulatory alignment and quality. You collaborate with sponsors and internal teams to deliver robust, timely statistical outputs. This role offers influence over study design, analysis strategies, and cross-functional decision-making within a mission-driven, collaborative environment. Your impact centers on advancing clinical programs to accelerate life-changing outcomes.
Pay / Benefits
- career development
- total rewards program
- supportive and engaged line management
Responsibilities
- Mentor biostatisticians and develop training plans
- Prepare SAPs and create mock-up displays for tables, listings, and figures
- Oversee statistical aspects of protocols and randomization schedules
- Review SAS CRFs, SAS database design, and study documentation
- Create or review programming specifications for datasets, tables, listings, and figures
- Direct and review work of other biostatistics personnel on projects
- Contribute to project teams as the biostatistics representative
- Ensure verification and quality control of deliverables
- Manage multi-project scheduling, timelines, and priorities
- Provide statistical programming support as needed
- Participate in DSMB/DMC activities or act as independent voting statistician
- Lead integrated analyses and participate in regulatory meetings as needed
- Ensure compliance with SOPs, WIs, and regulatory guidelines (ICH)
- Maintain documentation and inspection readiness
- Support business development through proposals and sponsor meetings
- Perform other duties and adapt to business needs
Key requirements
- collaborative
- communication
- team leadership
- SAS
- statistical analysis
- SAPs
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