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Principal Biostatistician
Job Summary
A company is looking for a Principal Biostatistician FSP, R Regulatory Submission.
Key Responsibilities
- Collaborate with project teams to establish objectives and timelines
- Write statistical sections of clinical trial protocols and analysis plans
- Monitor project activities and provide guidance to programming teams
Required Qualifications
- PhD in Statistics, Biostatistics, or related field with 5+ years of industry experience, or MS with 7+ years of experience
- At least 3 years of Phase 2/3 clinical trial experience
- Demonstrated ability to work independently in project management
- Experience using R for efficacy and safety analyses
- Understanding of ICH GCP, ICH E9, and industry practices
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COMPLETE JOB DESCRIPTION
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