Principal Biostatistician - Consultant

Principal Biostatistician - Contract

• Start Date: November 2026
• Location: Remote
• Pay: Hourly
• Pay Type: W2 (benefits available) or 1099

We are seeking an experienced Principal Biostatistician to support an upcoming NDA submission targeted for Q1–Q2 2027.

This is a hands-on consulting role focused on unblinded statistical review, final analysis support, data quality, and statistical oversight across a key late-stage clinical program.

Responsibilities

• Perform independent review and QC of unblinded statistical analyses and outputs.
• Support final database lock and final analysis activities.
• Review and troubleshoot statistical programming and analysis issues.
• Support Integrated Summary of Safety (ISS) activities.
• Oversee and coordinate work across the unblinded statistics and programming team.
• Work closely with cross-functional partners including Programming, Medical Writing, Regulatory, and Clinical teams.
• Help ensure consistency and accuracy across statistical analyses and study outputs.
• Manage appropriate communication and information flow between blinded and unblinded teams.
• Ensure statistical work is completed in line with FDA, ICH, GCP, CDISC, and company standards.
• Support responses to statistical questions and requests throughout the submission process.

Qualifications

• MS or PhD in Statistics, Biostatistics, or a related quantitative field.
• Strong hands-on biostatistics experience within clinical development.
• Experience supporting regulatory submissions and final analysis activities.
• Strong SAS programming knowledge and ability to independently review and troubleshoot statistical work.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Experience working within both blinded and unblinded clinical trial environments.
• Experience with integrated safety analyses / ISS preferred.
• Strong communication and cross-functional collaboration skills.
• Excellent attention to detail and ability to work against tight submission timelines.