Principal Biostatistician
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
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 CDISC standards
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
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 CDISC standards