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Amylyx Pharmaceuticals · 2 hours ago

Vice President, Biostatistics

Cambridge, MA

Full-time

Hybrid

Director/Executive

$312K/yr - $351K/yr

12+ years exp

Amylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs. The Vice President, Biostatistics will lead a team of Biostatisticians and play a pivotal role in the design, analysis, reporting and interpretation of clinical studies, ensuring strategic planning aligns with regulatory and commercial strategies.

BiotechnologyMedicalNeurosciencePharmaceutical

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

Qualification

PhD in statistics/biostatisticsStatistical methodologies expertiseSASR proficiencyRegulatory requirements knowledgeLeadership experienceProject management skillsDrug developmentCommunication skillsTeam collaboration

Required

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