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Principal Biostatistician
Job Summary
A company is looking for a Principal Biostatistician FSP for Early Phase.
Key Responsibilities
- Provide statistical support for drug development programs in early phases
- Collaborate with multi-disciplinary project teams to establish project timelines and provide statistical input to study protocols
- Write statistical analysis plans and contribute to clinical study reports and regulatory documents
Required Qualifications
- PhD in Statistics, Biostatistics, or related field with 5+ years of industry experience, or MS with 7+ years of experience
- Experience with regulatory submissions and successful publication experience
- Ability to use SAS and/or R for efficacy analyses
- Understanding of ICH GCP and industry practices
- Experience with CDISC standards, including SDTM and ADaM
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COMPLETE JOB DESCRIPTION
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