Associate Director, CMC Statistics

The Role:

Reporting to the Sr. Director, Manufacturing Sciences & Technology, this key subject matter expert within the CMC organization will be accountable for providing statistical oversight and analysis in support of clinical and commercial process development in readiness for BLA submission. This role performs or oversees the analysis of process development and production data, provides statistical interpretation of results, establishment of process and product specifications and collaborates on the reporting of results to cross functional teams and to support regulatory heath authority submissions. The individual in this position will have the unique opportunity to contribute to the rapid growth of a biotech startup.

Key Responsibilities: 

• 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, establishment and ownership of process monitoring program, and statistical process control 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 and evaluated in compliance with relevant regulatory requirements and Immunovant standards.
• Responsible for 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.
• Responsible for the statistical methods section of the reports. Identifies and corrects common flaws in the interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and ensures evaluation consistency.
• Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
• Effectively mentor peers on statistical methodologies and provide appropriate training to less experienced statisticians. Development of training guidelines related to statistical assessment.
• Close collaboration and ability to communicate effectively with non-statisticians imparting and delivering complex statistical information.

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.

 Work Environment:

• Remote based
• Dynamic, interactive, fast-paced, and entrepreneurial environment.
• Domestic or international travel are required (10%).

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.