Immunovant · 9 hours ago

Associate Director, CMC Statistics

United States

Full-time

Remote

Senior Level

$175K/yr - $185K/yr

5+ years exp

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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.

Qualification

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Statistical expertiseData analysisBiostatisticsStatistical methodologiesFDA regulationsDrug developmentCollaboration skills