Amylyx Pharmaceutical Corp.
Director, Biostatistics Cambridge, MA - Remote
Amylyx Pharmaceutical Corp., Cambridge, Massachusetts, us, 02140
Overview
Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts. Our mission is to develop novel therapies for high unmet needs, focusing on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Our culture is guided by core values: be audacious, be curious, be authentic, be engaged, and be accountable. We encourage you to read the opportunity and apply if you share our passion and determination. THE OPPORTUNITY Amylyx is seeking an experienced and motivated Director of Biostatistics. This role involves liaising with internal and external stakeholders (e.g., Clinical Development, Regulatory, Pharmacovigilance, Translational Sciences, Programming and Data Management, CROs) for the implementation of a clinical development program, regulatory submissions, and post-submission strategies/preparation/defense. Responsibilities
Provide strategic leadership of statistical approaches on an assigned therapeutic area or program, shaping clinical development plans from early design through regulatory submission, and serving as a statistical thought partner to cross-functional leaders and external stakeholders. Design and oversee implementation of robust, innovative trial designs that maximize probability of clinical and regulatory success, balancing scientific rigor with operational feasibility, while anticipating and proactively addressing potential regulatory challenges. Mentor, coach, and develop statisticians at varying levels of experience by providing technical guidance, fostering professional growth, and instilling best practices in statistical methods, data integrity, and regulatory compliance. Synthesize and present statistical insights by preparing data packages and cross-functional presentations, effectively communicating strategies, assumptions, and implications to leadership, regulatory bodies, and scientific audiences. Partner closely across functions to ensure alignment, collaboration, and timely execution of statistical deliverables that enable high-quality program success. Engage in occasional travel (Cambridge, MA and other locations) for collaboration and conferences, typically at least three times annually. Required Qualifications
PhD in Statistics/Biostatistics, Mathematics, or related quantitative fields with a minimum of 10 years, or MSc with a minimum of 14 years of experience with clinical trials including late-phase studies. Proficiency in scientific computing/programming (SAS or R) and implementation of advanced statistical analyses and simulations, deep knowledge of CDISC standards. Proficiency in the design of clinical trials Phases I – III, in applying knowledge of general and cutting-edge statistical / clinical trials methodologies to solve complex statistical problems in the clinical development programs and to ensure alignment with regulatory agencies and industry standards. Demonstrate skills in the analysis and reporting of clinical trials; experience with integrated summaries of safety and efficacy (ISS and ISE). Prior experience in interactions with regulatory and health authorities is a plus. Work Location and Conditions
We support remote work opportunities within the United States. Some states are excluded due to business considerations related to health insurance coverage and state tax regulations. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan, and Tennessee. Travel to our Cambridge, MA location and other company-related events is expected several times per year. You must have access to a work setting that enables meeting all role requirements (privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location. To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. Equal Opportunity Employer
Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, or any other characteristic protected by applicable federal, state, or local laws. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
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Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts. Our mission is to develop novel therapies for high unmet needs, focusing on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Our culture is guided by core values: be audacious, be curious, be authentic, be engaged, and be accountable. We encourage you to read the opportunity and apply if you share our passion and determination. THE OPPORTUNITY Amylyx is seeking an experienced and motivated Director of Biostatistics. This role involves liaising with internal and external stakeholders (e.g., Clinical Development, Regulatory, Pharmacovigilance, Translational Sciences, Programming and Data Management, CROs) for the implementation of a clinical development program, regulatory submissions, and post-submission strategies/preparation/defense. Responsibilities
Provide strategic leadership of statistical approaches on an assigned therapeutic area or program, shaping clinical development plans from early design through regulatory submission, and serving as a statistical thought partner to cross-functional leaders and external stakeholders. Design and oversee implementation of robust, innovative trial designs that maximize probability of clinical and regulatory success, balancing scientific rigor with operational feasibility, while anticipating and proactively addressing potential regulatory challenges. Mentor, coach, and develop statisticians at varying levels of experience by providing technical guidance, fostering professional growth, and instilling best practices in statistical methods, data integrity, and regulatory compliance. Synthesize and present statistical insights by preparing data packages and cross-functional presentations, effectively communicating strategies, assumptions, and implications to leadership, regulatory bodies, and scientific audiences. Partner closely across functions to ensure alignment, collaboration, and timely execution of statistical deliverables that enable high-quality program success. Engage in occasional travel (Cambridge, MA and other locations) for collaboration and conferences, typically at least three times annually. Required Qualifications
PhD in Statistics/Biostatistics, Mathematics, or related quantitative fields with a minimum of 10 years, or MSc with a minimum of 14 years of experience with clinical trials including late-phase studies. Proficiency in scientific computing/programming (SAS or R) and implementation of advanced statistical analyses and simulations, deep knowledge of CDISC standards. Proficiency in the design of clinical trials Phases I – III, in applying knowledge of general and cutting-edge statistical / clinical trials methodologies to solve complex statistical problems in the clinical development programs and to ensure alignment with regulatory agencies and industry standards. Demonstrate skills in the analysis and reporting of clinical trials; experience with integrated summaries of safety and efficacy (ISS and ISE). Prior experience in interactions with regulatory and health authorities is a plus. Work Location and Conditions
We support remote work opportunities within the United States. Some states are excluded due to business considerations related to health insurance coverage and state tax regulations. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan, and Tennessee. Travel to our Cambridge, MA location and other company-related events is expected several times per year. You must have access to a work setting that enables meeting all role requirements (privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location. To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. Equal Opportunity Employer
Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, or any other characteristic protected by applicable federal, state, or local laws. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
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