Director, Biostatistics

Amylyx Pharmaceuticals•Cambridge, MA

3d•Remote

About The Position

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 and apply. The Opportunity Amylyx is seeking an experienced and motivated Director of Biostatistics. In this role you will liaise with various 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.

Requirements

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 hands-on 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 considered a plus.
Excellent written, verbal, and interpersonal communication skills, and strong negotiation, and organizational skills; must be able to work independently.
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.

Nice To Haves

Prior experience in interactions with regulatory and health authorities considered a plus.

Responsibilities

Provide strategic leadership of statistical approaches on an assigned therapeutic area or a program, shaping clinical development plans from early design through regulatory submission and post-submission activities.
Serve as a statistical lead and thought partner to cross-functional teams and external stakeholders.
Lead the design and oversight of robust, innovative clinical trial designs that maximize probability of clinical and regulatory success, balancing scientific rigor with operational feasibility, while anticipating and proactively addressing potential regulatory challenges.
Oversee and/or contribute to key statistical deliverables, including protocols, statistical analysis plans, table/listing/figure shells, clinical study reports, integrated summaries of safety and efficacy, briefing documents, regulatory responses, and submission materials.
Oversee CRO and vendor statistical and programming activities to ensure quality, consistency, timeliness, and alignment with regulatory standards and company expectations.
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 to Cambridge, MA and other locations for collaboration and conferences, typically at least three times annually.