Vice President, Biostatistics

THE OPPORTUNITY

The Vice President, Biostatistics will lead a team of Biostatisticians and play a pivotal role in driving the statistical the 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 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
• 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

• PhD or equivalent advanced degree in statistics/biostatistics with 12+ years relevant work experience within pharmaceutical or biotechnology industry
• Exemplary leadership, strategic thinking, and technical expertise in statistical analysis, with a proven track record of leading a high performing biometrics team
• Expert knowledge of statistical methodologies such as longitudinal data analysis, Bayesian modeling and adaptive designs
• Working knowledge of statistical and data processing software e.g., SAS and/or R
• Good understanding of worldwide regulatory requirements and clinical trial expertise from early phase to late phase. NDA/MAA submission experience is desired
• Strong oral and written communication skills. Ability to function effectively in a team and cross-functional environment
• Advanced knowledge of the pharmaceutical industry, and overall drug development process
• Strong project management skills. An understanding of biology of disease and drug discovery.

WORK LOCATION AND CONDITIONS

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.