Director, Biostatistics
Kiniksa Pharmaceuticals · Lexington, MA
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Role summary
Kiniksa Pharmaceuticals seeks a Director of Biostatistics to lead statistical strategies across multiple research and development programs. The role involves designing clinical studies, overseeing statistical analyses, and ensuring regulatory compliance for biopharmaceutical development in a collaborative, cross-functional environment.
What they're looking for
- PhD in statistics or biostatistics with minimum 8 years pharma/biotech experience
- Advanced knowledge of clinical study designs, descriptive and inferential statistics
- Strong SAS programming skills with proficiency in R and relevant software
- Expertise in IND, NDA, MAA submissions and regulatory guidance documents
- Experience with clinical research and cross-functional collaboration
- Strong project management and communication skills
What you'll be doing
- Lead statistical strategy as primary statistician on one or more clinical development projects
- Develop and implement statistical analysis plans, protocols, and clinical study reports
- Oversee database definition, quality standards, and coordinate with data management teams
- Conduct statistical analyses for clinical trials and evaluate alternative methodologies
- Provide technical oversight of external statistical vendors and regulatory submissions
Privacy & handoff
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