Associate Director, CMC Statistics

Summary

Join Immunovant, Inc., a clinical-stage immunology company, as a Statistical expert contributing to the development of innovative therapies for autoimmune diseases. Reporting to the Sr. Director, Manufacturing Sciences & Technology, you will provide statistical oversight and analysis for clinical and commercial process development. Key responsibilities include statistical analysis of process data, specification development, and collaboration with cross-functional teams. This role requires a PhD or MS in a relevant field and significant experience in the biotech/pharmaceutical industry. The position offers a remote work environment, a competitive salary, and a comprehensive benefits package including unlimited paid time off and parental leave. This is a unique opportunity to contribute to the growth of a biotech startup.

Requirements

• PhD or MS in Statistic, Biostatistics, Mathematics, or related field
• For Associate Director: 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 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

Responsibilities

• Provide 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
• Assess clinical and commercial production data, product stability trending and evaluation, establishment and ownership of process monitoring program, and statistical process control evaluation
• Support data collection, analysis, and data management activities
• Develop, deliver and communicate statistical analyses, data presentations, and scientific reports
• Ensure that data for statistical analyses are complete, accurate, and consistent and evaluated in compliance with relevant regulatory requirements and Immunovant standards
• Ensure the accuracy and consistency of data statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings
• Be responsible for the statistical methods section of the reports. Identify and correct common flaws in the interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and ensure evaluation consistency
• Demonstrate extensive understanding of statistical concepts and methodologies. Recognize and correct flaws in scientific reasoning and statistical interpretation
• Effectively mentor peers on statistical methodologies and provide appropriate training to less experienced statisticians. Develop training guidelines related to statistical assessment
• Closely collaborate and communicate effectively with non-statisticians, imparting and delivering complex statistical information

Benefits

• Remote based work environment
• Full range of medical, dental, vision benefits
• 401k
• Unlimited paid time off
• Parental leave
• Equity and other forms of compensation may be provided as part of a total compensation package