Job Summary

A clinical-stage biopharmaceutical company needs applicants for an opening for a Remote Biostatistics Senior Director in Waltham.

Individual must be able to fulfill the following responsibilities:

• Serve as the lead statistician and manage statistical efforts
• Represent the biometrics functions in the program teams
• Serve as the biostatistical lead in regulatory submissions and inspections

Position Requirements Include:

• MS in statistics or equivalent with 12 years of relevant clinical trial experience
• Knowledge of statistical methods for clinical trials
• In-depth Knowledge of FDA, EMA and ICH regulations and guidelines
• Experience with NDAs/BLAs, MAAs and other regulatory submissions
• Experience of managing director reports as a line manager
• Proficient in statistical programming (SAS is required)