Vice President, Data Science and Analytics
Alto PharmacySalary not specified
[Remote] Vice President, Biostatistics at Amylyx Pharmaceuticals
Cambridge, Massachusetts, United States
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
- PhD or equivalent advanced degree in statistics/biostatistics with 12+ years relevant work experience within pharmaceutical or biotechnology industry
- Exemplary leadership, strategic thinking, and technical expertise in statistical analysis, with a proven track record of leading a high performing biometrics team
- 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 a strategic leadership role in the Biometrics Team and cross-departmental program team to ensure the biometrics scopes and timelines defined to meet the corporate objectives
- Lead and manage the biostatistics team and provide statistical strategies to drug development including development plans, innovative or adaptive study designs, and cross-study analyses including basic and complex statistical methodology implementation, data interpretations, regulatory submissions
- Act at 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 and determine appropriate statistical methodologies for analysis; analyze data and interpret results from clinical trials to meet objectives of the study protocol
- Mentor biostatisticians and oversee execution of major statistics deliverables and milestones in collaboration with other functions
- Build and maintain a partnership with CROs or individual consultants as needed, provide statistical oversight to tasks outsourced and assure adequate quality and consistency with company and industry standards
- Participate and collaborate in database design meetings as needed to ensure high quality data evaluated and analysis requirements satisfied
- Review and approve responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators
- Review and ensure the accuracy of Statistical Review Aids submitted to regulatory agencies
- Ensure compliance with GCP and other regulatory requirements
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary for the Vice President, Biostatistics position?
This information is not specified in the job description.
Is this Vice President, Biostatistics role remote or office-based?
This information is not specified in the job description.
What key skills and experience are required for the Vice President, Biostatistics role?
The role requires leadership in biostatistics for clinical studies, expertise in statistical strategies including innovative or adaptive study designs, complex statistical methodology, data interpretation, and regulatory submissions, plus experience managing teams and overseeing CRO partnerships.
What is the company culture like at Amylyx Pharmaceuticals?
Amylyx fosters a culture of caring powered by core values – be audacious, be curious, be authentic, be engaged, and be accountable – with an experienced team pursuing opportunities with urgency, rigorous science, and commitment to communities.
What makes a strong candidate for the Vice President, Biostatistics position?
Strong candidates share the passion for tackling medicine’s toughest problems, have experience leading biostatistics teams in clinical development, strategic planning for regulatory submissions, and building partnerships with CROs.
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
