Amylyx Pharmaceuticals

Amylyx Pharmaceuticals

Director, Biostatistics

Cambridge, MA · Director

Sponsorship not specified$221k-$249kDetected 8 days ago
StatisticsNegotiationRecruitingClinical TrialsPharmacovigilanceSASLeadershipCommunicationCollaborationPublic SpeakingOrganizational SkillsBiostatistics

About the role

  • Amylyx is seeking an experienced and motivated Director of Biostatistics.

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.
  • 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.
  • Partner closely across functions to ensure alignment, collaboration, and timely execution of statistical deliverables that enable high-quality program success.

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.
  • experience with integrated summaries of safety and efficacy (ISS and ISE).
  • must be able to work independently.

Compensation

  • The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks.
  • Estimated Pay Range
  • $221,000 - $249,000 USD
  • 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.

Benefits

  • Prior experience in interactions with regulatory and health authorities considered a plus.
  • 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.
  • The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.

Company info

  • 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
  • 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.
  • Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee.
  • At Amylyx, we proudly support remote work opportunities within the United States.

Equal opportunity

  • If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Visa & Work Authorization

  • 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 condition
Apply directly at Amylyx Pharmaceuticals →Create a free account for alerts like thisView Amylyx Pharmaceuticals immigration profile

This listing is sourced directly from Amylyx Pharmaceuticals's careers page and normalized into a canonical job model.