Principal Biostatistician
A company is looking for a Principal Biostatistician, FSP, Late Phase.
Key Responsibilities
Collaborate with multi-disciplinary project teams to establish project objectives and timelines
Write statistical sections of clinical trial protocols and author statistical analysis plans
Monitor project activities and provide guidance to programmers on analysis dataset specifications
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
Ability to use R or SAS for efficacy and safety analyses
Understanding of ICH GCP, ICH E9, and industry practices
Experience with CDISC standards including SDTM, ADAM, and CDASH
A company is looking for a Principal Biostatistician, FSP, Late Phase.
Key Responsibilities
Collaborate with multi-disciplinary project teams to establish project objectives and timelines
Write statistical sections of clinical trial protocols and author statistical analysis plans
Monitor project activities and provide guidance to programmers on analysis dataset specifications
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
Ability to use R or SAS for efficacy and safety analyses
Understanding of ICH GCP, ICH E9, and industry practices
Experience with CDISC standards including SDTM, ADAM, and CDASH