[Remote] Director, Biostatistics at Amylyx Pharmaceuticals

Cambridge, Massachusetts, United States

Apply Now

Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Candidates must possess a PhD in Statistics, Biostatistics, Mathematics, or a related quantitative field with at least 10 years of experience in clinical trials, including late-phase studies, or an MSc with at least 14 years of experience. Proficiency in SAS or R programming, advanced statistical analyses, simulations, and CDISC standards is required. Experience in designing Phase I-III clinical trials, applying statistical methodologies to solve complex problems, and analyzing/reporting clinical trials, including integrated summaries of safety and efficacy, is essential. Prior experience interacting with regulatory and health authorities is considered a plus.

Responsibilities

The Director of Biostatistics will provide strategic leadership for statistical approaches within assigned therapeutic areas or programs, shaping clinical development plans from design through regulatory submission. Responsibilities include designing and overseeing innovative trial designs, mentoring statisticians, synthesizing and presenting statistical insights to various audiences, and partnering across functions to ensure timely execution of statistical deliverables. Occasional travel for collaboration and conferences is expected.

Skills

Biostatistics

Clinical Development

Regulatory Submissions

Trial Design

Statistical Leadership

Mentoring

Coaching

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

Try Jobo Free