Imagine working for a company that is working to go beyond treating the symptoms of genetic disease by trying to stop its progress at its underlying cause.
That’s what we do every day at Lexeo Therapeutics.
We’re not content to simply make better therapies – we want to change the arc of medicine. That passion drives us, and we look for it in every person we bring to our team.
Ready to be a part of it? See our openings below.
COMPANY BENEFITS:
Health Insurance & Wellness benefits
Health, dental and vision benefits
Flexible Spending Account (FSA)
Health Savings Account (HSA)
Disability insurance
Life insurance
Mental health benefits
Perks & Discounts
Commuter benefits
Tech stipend
Stocked kitchen
In office lunch stipend
Retirement & Stock option benefits
401(K) with company match
Performance bonus
Company equity
Vacation & Time off benefits
Unlimited PTO
Paid holidays
Paid parental leave
Clinical Development
Director/Senior Director, Clinical Statistician
Hybrid / Full time
New York, New York, US
The Director/Senior Director, Clinical Statistician will lead and manage biostatistical activities across a complex portfolio of gene therapy studies and other projects. You will collaborate with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, serving as the statistics lead on project teams, providing statistical input on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans, ensuring analyses are completed appropriately and accurately, and that study results and conclusions in scientific publications/presentations and regulatory filings are scientifically sound and supported by the statistical analyses.
You will be responsible for the analysis of interim and final data sets and will oversee data and programming deliverables accountable by the CRO.
Lexeo has a hybrid work culture but is open to remote candidates within the US for this role.
Primary Responsibilities
Responsible for biostatistical activities for a complex portfolio of clinical studies for gene therapy programs
Ensures timely and appropriate gathering, organization, and analysis of different data sources to support clinical trial design and clinical study endpoints
Lead statistical input to clinical trial design and protocol development
Author statistical analysis plans in conjunction with the clinical team
Align the requirements for data reporting, tables, listings, and figures required for interim and final reports, including topline reports and final clinical study reports
Oversees and directs completion of all technical and operational statistical activities Directs internal and external teams in the definition, execution, and completion of statistical activities for programs
Contribute to clinical development planning for the portfolio
Provide timely and appropriate advice to internal and external partners on statistical analysis strategies, reliability of measurements, and identifiability of models
Reviews and approves biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory documentation, ensuring accuracy of the data, that data are presented clearly, and the conclusions drawn are scientifically sound and supported by the statistical analyses
Represent statistics function with senior management and other external partners, including regulatory agencies
Typically takes a lead in special projects that can benefit the portfolio, such as new methodologies, processes, technology, and other tools, and may also lead the development and/or implementation of SOPs and related documentation
Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Lexeo’s SOPs
Required Skills & Qualifications
PhD in biostatistics or related discipline with 8+ years’ relevant experience in statistical analysis of biomedical data using SAS or equivalent software in the biopharma industry or a related environment
MS in biostatistics or related discipline with 10+ years’ relevant experience in statistical analysis of biomedical data using SAS or equivalent software
Extensive biomedical statistical analysis experience and experience working with relevant software
Experience developing software and other tools to support statistical analysis of biomedical or related data. Strong proficiencies in software and other tools typically used by Biostatistics
Demonstrated excellence in complex project management and effectively managing multiple projects and priorities
Experience working with CROs for data and programming deliverables
Expert level of knowledge of biostatistics, as evidenced by independence in assuming responsibilities for complex Phase 1-3 gene therapy projects
Advanced knowledge of biostatistics best practices and tools and has shown the ability to apply this to improve overall results
Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes
In-depth understanding of the cross-functional roles and responsibilities involved in drug development
Knowledge of FDA and EMA regulations, ICH guidelines, GCP, and familiarity with standard clinical procedures
Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees
When needed, the ability to travel
Ability to handle multiple development programs simultaneously
Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
Excellent written and verbal communication skills demonstrated by ability to present clear instruction/direction
Analytical and problem-solving capabilities
Collaborative and collegial work style
Attention to detail and follow-up
$200,000 - $280,000 a year
Base salary dependent on qualifications and overall experience.
About Lexeo
Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of clinical and preclinical programs. Lexeo successfully completed a $112M IPO in November 2023 and in early March 2024 announced a PIPE raising an additional $95M, extending the Company’s runway into 2027.
Our work culture for most roles is a hybrid model with days in the New York City office and days working from home. We welcome applications from candidates located across the Northeast and Mid-Atlantic. Remote work can be considered for exceptional candidates.
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.
