Director/Senior Director, Clinical Statistician

The DirectorSenior 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 publicationspresentations 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 ResponsibilitiesResponsible for biostatistical activities for a complex portfolio of clinical studies for gene therapy programsEnsures timely and appropriate gathering, organization, and analysis of different data sources to support clinical trial design and clinical study endpointsLead statistical input to clinical trial design and protocol developmentAuthor statistical analysis plans in conjunction with the clinical teamAlign the requirements for data reporting, tables, listings, and figures required for interim and final reports, including topline reports and final clinical study reportsOversees 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 programsContribute to clinical development planning for the portfolioProvide timely and appropriate advice to internal and external partners on statistical analysis strategies, reliability of measurements, and identifiability of modelsReviews 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 analysesRepresent statistics function with senior management and other external partners, including regulatory agenciesTypically 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 andor implementation of SOPs and related documentationAdheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Lexeo's SOPsRequired Skills & QualificationsPhD 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 environmentMS in biostatistics or related discipline with 10+ years' relevant experience in statistical analysis of biomedical data using SAS or equivalent softwareExtensive biomedical statistical analysis experience and experience working with relevant softwareExperience developing software and other tools to support statistical analysis of biomedical or related data. Strong proficiencies in software and other tools typically used by BiostatisticsDemonstrated excellence in complex project management and effectively managing multiple projects and prioritiesExperience working with CROs for data and programming deliverablesExpert level of knowledge of biostatistics, as evidenced by independence in assuming responsibilities for complex Phase 1-3 gene therapy projectsAdvanced knowledge of biostatistics best practices and tools and has shown the ability to apply this to improve overall resultsDemonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomesIn-depth understanding of the cross-functional roles and responsibilities involved in drug developmentKnowledge of FDA and EMA regulations, ICH guidelines, GCP, and familiarity with standard clinical proceduresStrong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committeesWhen needed, the ability to travelAbility to handle multiple development programs simultaneouslyExcellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skillsExcellent written and verbal communication skills demonstrated by ability to present clear instructiondirectionAnalytical and problem-solving capabilitiesCollaborative and collegial work styleAttention to detail and follow-up$200,000 - $280,000 a yearBase salary dependent on qualifications and overall experience.About LexeoLexeo 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.

Created: 2025-02-17