Principal Biostatistician

Job Summary

A company is looking for a Principal Biostatistician FSP - Clinical Development.

Key Responsibilities

• Provide statistical support to clinical studies, focusing on Neurology
• Participate in the development of study protocols and statistical analysis plans (SAPs)
• Perform statistical analyses and prepare clinical study reports for submissions

Required Qualifications

• Master's degree in statistics or a related discipline; PhD strongly desired
• 5+ years of experience supporting clinical trials in the Pharmaceutical or Biotechnology industry
• Experience in sample size calculation, protocol development, and SAP preparation
• Good SAS programming skills; knowledge of R programming is a plus
• Strong knowledge of ICH guidelines and CDISC requirements for regulatory submissions