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Director, Biostatistics

Cambridge, MA - Remote

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve.

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – create 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 determination, 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.

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 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 considered a plus.

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, Delaware, Hawaii and Kansas.
  • 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.

 

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Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived 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, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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