[Remote] Director, Biostatistics at Amylyx Pharmaceuticals

Cambridge, Massachusetts, United States

Amylyx Pharmaceuticals Logo
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries

Skills

Key technologies and capabilities for this role

BiostatisticsClinical DevelopmentRegulatory SubmissionsTrial DesignStatistical LeadershipMentoringCoaching

Questions & Answers

Common questions about this position

What qualifications are required for the Director of Biostatistics role?

A PhD in Statistics/Biostatistics, Mathematics, or related quantitative fields with at least 10 years of experience in clinical trials including late-phase studies is required, or an MSc with a minimum of 14 years of such experience. Proficiency in scientific computing/programming (SAS or R) and implementation of advanced statistical analyses and simulations, along with deep knowledge of CDISC standards, is also required.

Is this a remote position, or is there a location requirement?

The role is based in Cambridge, Massachusetts, and involves occasional travel to Cambridge, MA and other locations for collaboration and conferences, typically at least three times annually.

What are Amylyx Pharmaceuticals' core values and company culture like?

Amylyx's core values are to be audacious, be curious, be authentic, be engaged, and be accountable, creating a culture of caring. The company has assembled an experienced team ready to take action with urgency, rigorous science, and commitment to the communities they serve.

What is the salary or compensation for this position?

This information is not specified in the job description.

What experience makes a strong candidate for this Director of Biostatistics role?

Candidates with a PhD (10+ years) or MSc (14+ years) in relevant quantitative fields, proficiency in SAS or R, advanced statistical analyses experience in late-phase clinical trials, and deep CDISC knowledge will stand out, especially with leadership in clinical development programs.

Amylyx Pharmaceuticals

Develops treatments for neurodegenerative diseases

About Amylyx Pharmaceuticals

Amylyx Pharmaceuticals develops treatments for neurodegenerative diseases, focusing on conditions like Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's Disease (ALZ). Their main product, AMX0035, is currently undergoing clinical trials to assess its effectiveness. The CENTAUR ALS trial showed promising results for ALS patients, using a randomized, double-blind, placebo-controlled design to ensure reliable outcomes. They are also conducting the PEGASUS trial to evaluate AMX0035's safety and effectiveness in Alzheimer's patients. Unlike many competitors, Amylyx emphasizes community engagement and awareness campaigns, such as ALS Awareness Month, to educate the public and foster support for those affected by these diseases. The company's goal is to bring effective therapies to market that improve patient outcomes and enhance the quality of life for individuals suffering from neurodegenerative conditions.

Cambridge, MassachusettsHeadquarters
2013Year Founded
$166.7MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees

Benefits

Remote Work Options

Risks

Relyvrio's Phase III failure raises concerns about ALS treatment efficacy.
Low stock offering price suggests potential financial instability.
New CCO may disrupt commercialization strategies if not aligned with goals.

Differentiation

Amylyx focuses on neurodegenerative diseases like ALS and Alzheimer's.
AMX0035 is a promising drug for ALS and Alzheimer's treatment.
Amylyx engages in community awareness campaigns for neurodegenerative diseases.

Upsides

Positive Phase II results for AMX0035 in ALS boost its potential.
Partnership with Gubra accelerates drug development for neurodegenerative diseases.
Regulatory support for rare diseases aids Amylyx's Wolfram syndrome efforts.

Land your dream remote job 3x faster with AI