Director, Clinical Statistician

Primary Responsibilities

Author statistical analysis plans in conjunction with the clinical team
Responsible for biostatistical activities for a complex portfolio of clinical studies for gene therapy programs.
Where applicable, oversees and directs statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with own team, other Biostatistics team members, CROs, and cross-functional partners. Ensures appropriate statistical consultation on trial design and study endpoints and timely and well-executed authoring of statistical analysis plans.
Align the requirements for data reporting, tables, listings, and figures required for interim and final reports, including topline reports and final clinical study reports.
Where applicable, oversees, and contributes to completion of all technical and operational statistical activities for a portfolio of clinical trials. Directs internal and external teams in the definition, execution and completion of statistical activities for disease or therapeutic area products of considerable complexity.
Contribute to clinical study designs and clinical development planning for the portfolio.
Where applicable, advises or otherwise ensures timely and appropriate advice to internal and external partners on statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
Ensures timely and appropriate gathering, organization, and analysis of different data sources to enable delivery of the statistical analysis plan and clinical study endpoints for clinical studies.
Reviews and approves biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
Typically takes a lead in special projects that can benefit multiple biostatistics team members, such as new methodologies, processes, technology and other tools, and may also lead the development and / or implementation of SOPs and related documentation.
Provide statistical leadership in clinical study team setting.
May independently present at department, project team, or Sr. Management meetings.
Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and LEXEO’s SOPs. 

Required Skills and Qualifications

• PhD in biostatistics or related discipline with 8+ years (10+ years with MS) relevant experience in statistical analysis of biomedical data using SAS or equivalent software in the biopharma industry or a related environment 
• 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 used 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.
• Experience leveraging AI and machine learning to enhance clinical trial design, analyses and decision-making is preferred.
• Expert-level of knowledge of biostatistics, as evidenced by independence in assuming responsibilities for complex Phase 1-3 gene therapy projects.
• Extensive knowledge of statistical designs, applicable to clinical trials in rare disease which allow for robust study results in smaller datasets.
• 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.
• 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.