Roivant Sciences, Inc., 320 West 37th Street, New York, NY 10018, United States
Immunovant, a subsidiary of Roivant Sciences, is a clinical stage biopharmaceutical company committed to developing innovative therapies for autoimmune diseases. Our lead asset, IMVT-1401, is in phase 2 clinical development for the treatment of multiple autoimmune diseases, with additional trials expected to start this year.
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 Roles and 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
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 fluid startup environment
Natural collaborator who enjoys working on a cross-functional team
Exceptional analytical, interpersonal, and communication skills