Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
Immunovant is seeking a Senior Director, Biostatistics to play a key role on a highly dynamic cross-functional team. In this role, you will be collaborating with both internal and external stakeholders to deliver the tactical execution of our Biostatistics strategy. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.
- 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
- Be accountable for statistics contributions to protocols, statistical analysis plans, randomization plans, study analysis conclusions, and other strategic and operational outputs.
- Be accountable for study level statistical deliverables on assigned projects, including timeliness and quality of deliverables according to project plans
- Provide oversight and review of statistical documents for multiple clinical trials, including SAPs,TLF shells and specifications of variable derivation.
- Develop effective collaborations with others within clinical teams and partner lines (such as Data Management and Regulatory)
- Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards
- Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports
- Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making
- Ph.D. in Statistic, Biostatistics, Mathematics or related field
- 12+ years of experience in biotechnology, pharmaceutical or health related area
- Knowledge of relevant FDA, EU, ICH guidelines and regulations.
- 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
- Immunovant’s headquarter 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%)