Vice President, Biostatistics

Vice President, Biostatistics

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values be audacious, be curious, be authentic, be engaged, and be accountable creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems, we encourage you to read the opportunity below.

The Opportunity

The Vice President, Biostatistics will lead a team of Biostatisticians and play a pivotal role in driving the statistical design, analysis, reporting, and interpretation of clinical studies.

This highly interactive role will work closely with Clinical, Regulatory, Statistical Programming, Data Management, and other cross-functional experts. The Vice President, Biostatistics will build and maintain effective strategic working relationships with internal and external partners to meet business needs. This position will oversee the strategic planning of clinical development plans, as well as regulatory and commercial strategies to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.

Responsibilities

• 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 including basic and complex statistical methodology implementation, data interpretations, regulatory submissions
• Act as 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
• Provide guidance and support to develop individual protocols and data analysis plans and determine appropriate statistical methodologies for analysis; analyze data and interpret results from clinical trials to meet objectives of the study protocol
• 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

Required Qualifications

Work Location and Conditions

Estimated Pay Range $312,000 - $351,000 USD