Jim Li serves as the Senior Director and Head of Medical Affairs Biostatistics at Organon, where he leverages over 25 years of extensive experience in the biotechnology and pharmaceutical industry to drive innovative statistical strategies. In his current role, Jim leads the Biostatistics function for...
Jim Li serves as the Senior Director and Head of Medical Affairs Biostatistics at Organon, where he leverages over 25 years of extensive experience in the biotechnology and pharmaceutical industry to drive innovative statistical strategies. In his current role, Jim leads the Biostatistics function for Global Medical Affairs, focusing on Outcome Research and Real World Evidence (RWE) initiatives. His expertise in clinical trial design and analysis is pivotal in shaping the statistical framework for post-approval clinical trials and disease registries, ensuring that the methodologies employed are robust and aligned with regulatory standards.
Jim is instrumental in collaborating with cross-functional teams to develop and execute comprehensive publication plans that highlight key findings in therapeutic areas such as women's health, cardiovascular disease, rare diseases, neuroscience, psychiatry, and dermatology. His strategic oversight not only enhances the quality of clinical study reports (CSRs) but also fosters effective communication of results to stakeholders, thereby facilitating informed decision-making in the medical community.
With a strong foundation in real-world data analysis and evidence generation, Jim is adept at translating complex statistical concepts into actionable insights that support business development and regulatory submissions. His exceptional interpersonal and oral communication skills enable him to build effective relationships across diverse teams, driving collaboration and innovation within the organization. As a thought leader in biostatistics, Jim continues to contribute to the advancement of medical science, ensuring that Organon remains at the forefront of addressing unmet medical needs and improving patient outcomes.
