Remote Biostatistics Senior Director in Waltham

Location: Massachusetts

Compensation: To Be Discussed

Staff Reviewed: Thu, Jan 14, 2021

This job expires in: 18 days

Job Category: Healthcare

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced, Management

Education Level: Doctorate

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)

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