Director of Biostatistics

Job Summary

A company is looking for a Senior/Director of Biostatistics, Rare Disease, FSP.

Key Responsibilities:

• Lead cross-functional teams to ensure quality statistical strategy and regulatory compliance in clinical trial research
• Serve as a biostatistical consultant and represent sponsors in regulatory meetings
• Proactively identify risks to project delivery and implement strategies to mitigate them

Required Qualifications:

• MS or PhD in Biostatistics or related field with 10+ years of relevant experience
• Expertise in complex statistical methods for Phase 2-3 clinical trials
• Experience in regulatory submissions and preparation of submission datasets
• Strong knowledge of SAS or R and CDISC Data Standards
• Preferred experience in rare disease and immunology