Senior Biostatistician

Job Summary

A company is looking for a Biostatistician 5.

Key Responsibilities

• Provide statistical leadership and ensure alignment with clinical development standards and objectives
• Lead the development of Statistical Analysis Plans (SAPs) and provide statistical input into protocol design and key study documents
• Ensure deliverables meet quality standards and comply with regulatory guidelines

Required Qualifications

• MS or PhD degree in Biostatistics or a related field with 8+ years of relevant experience
• Expertise in complex statistical methods applicable to Phase 2-3 clinical trials
• Experience serving as a statistical lead for regulatory submissions
• In-depth knowledge of clinical research regulatory requirements and Good Clinical Practice (GCP)
• Strong working knowledge of SAS or R and CDISC Data Standards