Manager Biostatistics
Posted Apr 8, 2026
Key Responsibilities:
-
Provide statistical contributions, review, and quality control of study design documents, including Key Design Elements (KDE) and protocols. - Serve as the GBS lead on the Clinical Study Team Leadership Team to execute clinical trials according to the protocol, performing risk assessments, and ensuring quality data collection. - Oversee statistical contributions to key design elements, protocols, randomization specifications, and other study-related documentation. - Collaborate cross-functionally to deliver robust and scientifically rigorous analysis results in various communications. - Maintain statistics sections of the Trial Master File (TMF) and communicate effectively with stakeholders regarding study-specific findings. - Review deliverables from external suppliers for quality and contribute to process improvement initiatives. - Stay updated on developments in the field of statistics in drug development and assist with the development and implementation of technology utilizing AI. Qualifications Required:
-
MSc or PhD in Statistics, Biostatistics, or a related field. - At least 5 years of relevant industry experience for the Study Statistician role or at least 8 years for the Study Lead Statistician role. - Proven ability to apply statistical methods in clinical development. Key Responsibilities:
-
Provide statistical contributions, review, and quality control of study design documents, including Key Design Elements (KDE) and protocols. - Serve as the GBS lead on the Clinical Study Team Leadership Team to execute clinical trials according to the protocol, performing risk assessments, and ensuring quality data collection. - Oversee statistical contributions to key design elements, protocols, randomization specifications, and other study-related documentation. - Collaborate cross-functionally to deliver robust and scientifically rigorous analysis results in various communications. - Maintain statistics sections of the Trial Master File (TMF) and communicate effectively with stakeholders regarding study-specific findings. - Review deliverables from external suppliers for quality and contribute to process improvement initiatives. - Stay updated on developments in the field of statistics in drug development and assist with the development and implementation of technology utilizing AI. Qualifications Required: