Senior Biostatistician

Job Summary

Working remotely on a full-time basis, the Senior Biostatistician will develop statistical analysis plans, create randomization schedules, and lead projects across various phases while collaborating with clients and regulatory teams.

Key responsibilities:

• Create randomization and kit schedules, collaborating with sponsors and drug supply management teams
• Develop phase 1-4 statistical analysis plans (SAPs) and review statistical outputs while managing client meetings
• Provide support to Data Safety Monitoring Boards (DSMB) and prepare statistical sections of study protocols with minimal support

Required qualifications:

• College graduate in Biostatistics, Statistics, Mathematics, or related field; master's or PhD preferred
• Minimum of 5 years' experience in Biostatistics or a similar field
• Expert knowledge of SAS programming and statistical analysis
• Strong understanding of clinical data and drug development processes
• Excellent scientific writing skills and familiarity with regulatory requirements such as ICH guidelines and 21 CFR Part 11