[Remote] Vice President, Biostatistics at Amylyx Pharmaceuticals

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

PhD or equivalent advanced degree in statistics/biostatistics
12+ years relevant work experience within pharmaceutical or biotechnology industry
Exemplary leadership, strategic thinking, and technical expertise in statistical analysis
Expert knowledge of statistical methodologies such as longitudinal data analysis, Bayesian modeling, and adaptive designs
Working knowledge of statistical and data processing software (e.g., SAS and/or R)
Good understanding of worldwide regulatory requirements and clinical trials

Responsibilities

Provide strategic leadership role in the Biometrics Team and cross-departmental program team
Lead and manage the biostatistics team and provide statistical strategies to drug development
Act as the lead presenter of statistical data and results of clinical trials to senior management, regulatory agencies, or individual investigators
Oversee execution of statistical tasks, resources, timelines, and budgets for the function
Provide guidance and support to develop individual protocols and data analysis plans
Mentor biostatisticians and oversee execution of major statistics deliverables and milestones
Build and maintain partnerships with CROs or individual consultants
Participate in database design meetings to ensure high-quality data and analysis requirements
Review and approve responses to queries relating to study design, analysis, and interpretation
Review and ensure the accuracy of Statistical Review Aids submitted to regulatory agencies
Ensure compliance with GCP and other regulatory requirements

Skills

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.

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