Principal Biostatistician - MA Licensed

Job Summary

A company is looking for a Principal Biostatistician FSP, Clinical Safety (DMC/Unblinded).

Key Responsibilities

• Provide statistical leadership for early phase studies and conduct safety analyses for Phase 2/3 trials
• Serve as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements
• Participate in study design discussions and develop Statistical Analysis Plans (SAPs) and clinical study reports (CSRs)

Qualifications & Experience

• Master's degree in Statistics, Biostatistics, or a related discipline; PhD strongly preferred
• 5+ years of experience in clinical trials within the pharmaceutical or biotechnology industry; CRO experience preferred
• Proven experience in leading early phase clinical trials and conducting safety analyses for phase 2/3 trials
• Strong knowledge of ICH guidelines and regulatory expectations
• Proficient in SAS programming and solid understanding of CDISC standards for regulatory submissions