Senior Director, Biostatistics

Immunovant, Inc.

Completely RemoteFull TimeHealthcare & Telemedicine
Posted Today

Job description

About the Company

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

Responsibilities

  • Provide oversight and contributions to statistics strategy, planning, execution, and communication for assigned programs
  • Provide scientifically rigorous statistical input into clinical development plans, protocol development, and statistical analysis plans
  • Support regulatory submissions, questions, and interpretation of statistical analysis results
  • Develop effective collaborations with clinical teams and partner lines such as Medical Directors and Regulatory
  • Ensure all study and project level statistical activities comply with relevant regulatory requirements and company standards
  • Identify opportunities to utilize innovative statistical methodology to streamline clinical development
  • Manage indication and study biostatisticians

Requirements

  • PhD in Statistics, Biostatistics, Mathematics, or a related field
  • 12+ years of experience in biotechnology, pharmaceutical, or health-related areas
  • Knowledge of relevant Health Authority and ICH guidelines and regulations
  • Demonstrated experience engaging with Health Authorities
  • Comprehensive understanding of drug development from Phase 2 to launch
  • Strong written and oral communication skills with high attention to detail
  • Ability to collaborate with diverse sets of stakeholders in a fast-paced environment

Skills & tools

BiostatisticsClinical DevelopmentDrug Development

What the team is looking for

Use this list as a quick fit check before you apply.

  1. 01PhD in Statistics, Biostatistics, or Mathematics
  2. 0212+ years of biotech or pharma experience
  3. 03Knowledge of ICH guidelines
  4. 04Experience with Health Authority engagement
  5. 05Understanding of Phase 2 to launch drug development
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