Senior Director, Biostatistics

🕒 Junho 22

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Immunovant

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2018

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Immunovant é uma empresa focada no avanço de tratamentos para doenças autoimunes através de uma abordagem centrada no paciente. Com a visão de permitir vidas normais para pessoas com doenças autoimunes, a Immunovant aplica sua expertise em ciência para desenvolver e testar novas terapias. A empresa enfatiza as complexas e variadas necessidades em diferentes estágios e severidades das doenças. A Immunovant está comprometida em avançar suas áreas terapêuticas e ensaios clínicos, além de dialogar com pacientes, cuidadores e investidores sobre seus estudos em andamento e iniciativas corporativas.

Descrição

• Provide oversight and contributions to statistics strategy, planning, execution, and communication for programs as assigned. • Provide scientifically rigorous statistical input into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives. • Develop effective collaborations with others within clinical teams and partner lines (such as Medical Directors and Regulatory). • Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards. • Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making. • Manage indication/study biostatisticians.

🎯 Requisitos

• PhD. in Statistic, Biostatistics, Mathematics or related field • 12+ years of experience in biotechnology, pharmaceutical or health related area • Knowledge of relevant Health Authority and ICH guidelines, as well as regulations • Demonstrated experience in engaging with Health Authorities • Comprehensive understanding of drug development from Phase 2 to launch • Demonstrated ability to collaborate with diverse sets of stakeholders • Strong written and oral communication skills with attention to detail • Desire to work in a fast-paced, innovative environment • Natural collaborator who enjoys working on a cross-functional team

🏖️ Benefícios

• full range of medical, dental, vision • 401k • unlimited paid time off • parental leave