Temp - Biostatistician - Early Clinical Development
About the position
Responsibilities
• Provide support to a clinical study team on all relevant statistical matters under direct supervision.
• Participate in the preparation of study protocol and amendments.
• Perform relevant sample size calculations and write the statistical methodology section of the protocol.
• Review case report forms (CRF) and provide comments and feedback.
• Develop statistical analysis plans (SAP).
• Provide programming team with definitions and documentation for derived variables needed to produce planned Tables, Figures, and Listings (TFLs).
• Develop data and programming specifications jointly with programmers.
• Perform statistical analysis according to the SAP, validate analysis programs, and review TFLs.
• Prepare statistical methods and results sections for the clinical study report (CSR).
• Provide statistical insight into interpretation and discussion of study results.
• Support project-related activities including preparation of BLA submissions and oversee CRO deliverables.
Requirements
• Master's degree in Statistics/Biostatistics or related field required.
• 2+ years of relevant experience in early phase clinical trials.
Apply Now
Apply Now
Responsibilities
• Provide support to a clinical study team on all relevant statistical matters under direct supervision.
• Participate in the preparation of study protocol and amendments.
• Perform relevant sample size calculations and write the statistical methodology section of the protocol.
• Review case report forms (CRF) and provide comments and feedback.
• Develop statistical analysis plans (SAP).
• Provide programming team with definitions and documentation for derived variables needed to produce planned Tables, Figures, and Listings (TFLs).
• Develop data and programming specifications jointly with programmers.
• Perform statistical analysis according to the SAP, validate analysis programs, and review TFLs.
• Prepare statistical methods and results sections for the clinical study report (CSR).
• Provide statistical insight into interpretation and discussion of study results.
• Support project-related activities including preparation of BLA submissions and oversee CRO deliverables.
Requirements
• Master's degree in Statistics/Biostatistics or related field required.
• 2+ years of relevant experience in early phase clinical trials.
Apply Now
Apply Now