Summary. This position is responsible for leading statistical programming activities to support clinical development projects, regulatory submissions, and lifecycle management of biopharmaceutical products. This role ensures the accuracy, integrity, and compliance of clinical data analysis through advanced programming expertise and cross-functional collaboration. This position reports directly to the Senior Director and Head of Biometrics. Edu...
Summary. The Senior Director, Global Regulatory Affairs provides strategic regulatory leadership and direction across assigned development programs. This individual is responsible for developing and executing U.S. and EU regulatory strategies, ensuring successful interactions with health authorities, and driving compliance and regulatory excellence throughout the product lifecycle. Key Responsibilities. Develop and implement comprehensive U.S. an...
Summary. This position is responsible for providing statistical input to development strategies, and ensuring effective implementation, in order to support product development objectives within one or more therapeutic areas. As a key member of the statistical department, this role will be responsible for biostatistical activities for Gan & Lee projects, including design, analysis, and presentation of data to advance new product development, domes...
Summary. This position is responsible for providing statistical input to development strategies, and ensuring effective implementation, in order to support product development objectives within one or more therapeutic areas. As a key member of the statistical department, this role will be responsible for biostatistical activities for Gan & Lee projects, including design, analysis, and presentation of data to advance new product development, domes...
