• Ph.D. in Statistics/Biostatistics
• Submissions/ ISS and ISE experience
• Four or more years’ experience working as a Biostatistician
• Experience with writing/reviewing statistical analysis plans, working on study protocol, study design, and ad hoc analysis
• Possesses strong SAS programming skills
• In-depth knowledge of clinical development including clinical operations, data management, and clinical study report preparation workflow
• North American or European regulatory experience and in-depth knowledge of FDA/EU regulations and guidelines
• Excellent oral and written communication skills
• Ability to work on cross-functional teams is crucial
• Works well on a project team and possesses flexibility
• Minimum education requirement is a Master’s degree in Statistics or Biostatistics
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