Vice President, Biostatistics

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Requirements

• Provide a strategic leadership role in the Biometrics Team and cross-departmental program team to ensure the biometrics scopes and timelines defined to meet the corporate objectives
• Lead and manage the biostatistics team and provide statistical strategies to drug development including development plans, innovative or adaptive study designs, and cross-study analyses
• Act at the lead presenter of statistical data and results of clinical trials to senior management, regulatory agencies, or individual investigators
• Oversee execution of statistical tasks, resources, timelines and budgets for the function
• Mentor biostatisticians and oversee execution of major statistics deliverables and milestones in collaboration with other functions
• Build and maintain a partnership with CROs or individual consultants as needed, provide statistical oversight to tasks outsourced and assure adequate quality and consistency with company and industry standards
• Participate and collaborate in database design meetings as needed to ensure high quality data evaluated and analysis requirements satisfied
• Review and approve responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators
• Review and ensure the accuracy of Statistical Review Aids submitted to regulatory agencies
• Ensure compliance with GCP and other regulatory requirements