Associate Director, CMC Statistics - Remote

Overview

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

In Short

• Accountable for providing statistical expertise, data analysis and interpretation across the CMC organization.
• Provide statistical input for protocol development to ensure robustness, data quality and consistency.
• Provide statistical analysis of process development DOE results, data interpretation and support of specification development.
• Assessment of clinical and commercial production data, product stability trending and evaluation.
• Support data collection, analysis, and data management activities.
• Development, delivery and communication of statistical analyses, data presentations, and scientific reports.
• Ensures that data for statistical analyses are complete, accurate, and consistent.
• Responsible for the accuracy and consistency of data statistical tables, figures, and data listings.
• Effectively mentor peers on statistical methodologies.
• Close collaboration and ability to communicate effectively with non-statisticians.

Requirements

• PhD or MS in Statistic, Biostatistics, Mathematics, or related field.
• 5+ years of experience in biotechnology, pharmaceutical or health related area.
• Knowledge of relevant FDA, EU, ICH guidelines and regulations.
• Understanding of drug development and commercialization.
• Demonstrated ability to collaborate with diverse sets of stakeholders.
• Strong written and oral communication skills with attention to details.
• Desire to work in a fast-paced, innovative environment.
• Natural collaborator who enjoys working on a cross-functional team.

Benefits

• Equity and other forms of compensation may be provided.
• Full range of medical, dental, vision, 401k, and other benefits.
• Unlimited paid time off.
• Parental leave.