Organizational Overview:
Immunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.
The Role:
Immunovant is seeking a Head of Biostatistics to play a key role on a highly dynamic cross-functional development team. In this role, you will be responsible for leading all biostatistics activities and the future biostatistics teams for ongoing and future clinical trials and regulatory submissions for IMVT-1401 across a range of indications. The individual in this position will have the unique opportunity to grow and shape the biostatistics group of a rapid-growth biotech startup.
Key Responsibilities:
- Serve as a key member of the Clinical Leadership Team, contributing to the establishment of an effective, well-functioning organization
- Play a leadership role in the design of clinical trials, providing input on study design, trial size, endpoints, etc.
- Provide expert input to enable development plan next steps after key data readouts
- Author biostatistical sections of protocols and statistical analysis plans for IMVT-1401 studies across indications
- Author statistical section of regulatory submissions; provide input on submissions and regulatory strategy from a biostatistics perspective
- Build and manage internal Biostatistics team and provide oversight of CRO activities
- Establish and ensure compliance with Biostatistics SOPs
Requirements:
- 10+ years of clinical development experience, with an emphasis on statistics, statistical programming, and design and analysis of early and late-phase clinical studies
- Strong SAS programming skills; ability to review programming specifications
- Comprehensive knowledge of statistical analysis and global regulatory requirements relating to clinical development of pharmaceuticals
- Understanding of computer validation
- Able to advise on endpoint selection
- Direct experience with biologics is required; additional experience with small molecules preferred
- Experience with Immunology and Inflammation assets preferred
- Consistently able to produce quick, thorough, and accurate work
- Entrepreneurial spirit; willing to go above and beyond to manage multiple projects simultaneously and achieve key objectives in a fast-paced and fluidp environment
- Natural collaborator who enjoys working on a cross-functional team
- Exceptional analytical, interpersonal, and communication skills
- PhD or MS in Statistics or equivalent
Work Environment:
- Immunovant’s headquarters is located in New York City. The position is flexible for remote work.
- Dynamic, interactive, fast-paced and entrepreneurial environment
- Domestic or international travel may be required (<10%)