Organizational Overview:

Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies. Phase 2 clinical development is ongoing with Phase 3 preparations underway.

The Role:

Immunovant is seeking a Statistical Scientist 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 review support in the project specific design and programming of statistical tables, listings, figures, (TLF’s) and analysis datasets for clinical trials in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) set forth by Immunovant
  • Provide data review of blinded and unblinded data.
  • Coordinate with data management colleagues to facilitate and provide review tools to enable blind data review and data review in accordance with ICH E9.
  • Coordinate with data management and other team members to support data contributions to annual reports, Development Safety Update Reports (DSURs) per ICH E2F, investigator brochure updates, and other periodic data updates, as needed.
  • Investigate trends in statistics methodologies relative to alpha-spending rules, missing data accommodation, estimand specifications, and other topics, as needed, including monitoring clinicalatrials.gov website for current protocols, FDA.gov for current guidance, published statistical reviews, inspection reports, warning letters, and other relevant documents that pertain to statistics methodology.
  • Provide ad-hoc data displays using JMP or other software for in-house or exploratory data investigations.
  • Develop effective collaborations with others within clinical teams and partner lines (such as Data Management and Regulatory)
  • Foster productive partnerships with external vendors

  

Requirements:

 

  • BA/BS in relevant field
  • 3+ years of experience in the Healthcare industry
  • Ability to evaluate trends and data anomalies for purposes of ICHE9-relevant purposes.
  • Experience with FDA.gov and clinicaltrials.gov websites.
  • Working 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 project management skills with a proven track record of success
  • Strong written and oral communication skills with incredible attention to detail
  • Desire to work in a fast-paced, innovative environment
  • Natural collaborator who enjoys working on a cross-functional team

 

Work Environment:

  • The position will be located in Immunovant’s NC office
  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Domestic or international travel may be required (<10%)
This position has been filled.