Director, Clinical Statistician

Job description

Role Summary You 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, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans, and providing biostatistical input into clinical development plans, scientific publications and presentations, and regulatory filings. You will be responsible for the analysis of interim and final data sets and will oversee data and programming deliverables accountable by the CRO. A remote working model may be considered for exceptional candidates. 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...