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Principal Biostatistician
Job Summary
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
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COMPLETE JOB DESCRIPTION
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