Organizational Overview:

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in neonatal fragment crystallizable receptor (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 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.

The Role:

Immunovant is seeking an Associate 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.

Key Responsibilities:

  • Provide statistical inputs into protocol development, statistical analysis plans, interpretation of statistical analysis results, randomization plans
  • Provide oversight and review of statistical documents for multiple clinical trials, including TLF shells, eCRFs, and specifications of variable derivations.
  • Develop effective collaborations with others within clinical teams and partner lines (such as Statistical Programming, Data Management, Medical, Clinical Operations, and Regulatory)
  • Ensure that all study 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
  • Oversight statistics and programming vendors
  • Open to opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making

 

Requirements:

  • PhD or MS in Statistic, Biostatistics, Mathematics, or related field
  • 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area
  • Knowledge of relevant FDA, EU, ICH guidelines and regulations.
  • Understanding of drug development
  • 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

 

Work Environment:

  • Remote-based; access to Immunovant’s NYC and North Carolina offices available
  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Domestic or international travel may be required (~10%)

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