Biostatistician

Clinical Trials Biostatistician

Department of Clinical Sciences

Clinical Trials Unit

The Institute of Tropical Medicine (ITM) is internationally recognized as a centre of excellence for education, research and service provision in the field of tropical medicine. The Clinical Trials Unit (CTU) collaborates with clinical researchers at ITM and at partner institutions. The CTU is setting up and conducting clinical trials as well as other research studies in humans which address health problems in Belgium and in resource-limited settings in the South. To support the increasing number of projects coordinated by the CTU as well as other research activities within the Department of Clinical Sciences, we are looking forward to extend our team with a clinical trials biostatistician.

If you would like to contribute to international health research and are eager to become part of a committed team, you could be the colleague we are looking for!

Assignment

As the CTU statistician, you provide statistical expertise and perform statistical activities for all clinical trials and clinical trial-related research at the ITM. In addition, you provide statistical support to researchers, PhD and Master students from the Department of Clinical Sciences.

Supervise and coordinate the assignments of the CTU statisticians and allocate new assignments within the team.

Provide statistical input in study protocol (trial design, sample size calculation, randomization and data analysis section) and in the development of case report forms and clinical trial database.

Prepare statistical analysis plans, prepare and test statistical analysis programs (in SAS, Stata, or R).

Perform statistical analysis and interpret clinical trial data, prepare statistical methods and results sections of the clinical study report and manuscripts.

Prepare reports to Data Safety Monitoring Boards of clinical trials.

Interact with CTU colleagues (Data Management, Clinical Research Scientists) and ITM researchers to give statistical input and guidance.

Assist in the development of data collection tools and databases.

Be a member of Research Consortia and Trial Management Groups, co-determinate the projects’ design and stimulate interdisciplinary collaboration within projects.

Contribute to the strengthening of clinical trials capacities and statistical expertise of partner institutes in the developing world. This may involve travelling to the study sites in developing countries.

Ensure the conduct of statistical activities according to ICH-GCP guidelines and ITM SOPs.

Contribute to the preparation and review of SOPs related to data handling and data analysis in clinical trials and other research studies at ITM.

Participate in educational and training activities related to statistics and clinical trial methodology, within ITM and externally at partner institutions and collaborators.

If you would like to contribute to international health research and are eager to become part of a committed team, you could be the colleague we are looking for!

Assignment

• As the CTU statistician, you provide statistical expertise and perform statistical activities for all clinical trials and clinical trial-related research at the ITM. In addition, you provide statistical support to researchers, PhD and Master students from the Department of Clinical Sciences.
• Supervise and coordinate the assignments of the CTU statisticians and allocate new assignments within the team.
• Provide statistical input in study protocol (trial design, sample size calculation, randomization and data analysis section) and in the development of case report forms and clinical trial database.
• Prepare statistical analysis plans, prepare and test statistical analysis programs (in SAS, Stata, or R).
• Perform statistical analysis and interpret clinical trial data, prepare statistical methods and results sections of the clinical study report and manuscripts.
• Prepare reports to Data Safety Monitoring Boards of clinical trials.
• Interact with CTU colleagues (Data Management, Clinical Research Scientists) and ITM researchers to give statistical input and guidance.
• Assist in the development of data collection tools and databases.
• Be a member of Research Consortia and Trial Management Groups, co-determinate the projects’ design and stimulate interdisciplinary collaboration within projects.
• Contribute to the strengthening of clinical trials capacities and statistical expertise of partner institutes in the developing world. This may involve travelling to the study sites in developing countries.
• Ensure the conduct of statistical activities according to ICH-GCP guidelines and ITM SOPs.
• Contribute to the preparation and review of SOPs related to data handling and data analysis in clinical trials and other research studies at ITM.
• Participate in educational and training activities related to statistics and clinical trial methodology, within ITM and externally at partner institutions and collaborators.