The Institute of Tropical Medicine (ITM) is internationally recognised 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!
- Provide statistical expertise and perform statistical activities for all clinical trials and clinical trial-related research at the ITM. In addition, 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, randomisation 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 project designs 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.
- Master in biostatistics or applied statistics.
- A least five years of experience in biostatistics with a minimum of three years of experience in statistical analysis and programming of clinical trials data.
- Good knowledge of and interest in statistical techniques applicable to clinical research: survival analysis, longitudinal analyses, generalised linear models, and missing data methods.
- Sound knowledge of ICH-GCP guidelines for clinical trials.
- Thorough technical knowledge of one or more of the following statistical software packages: SAS, Stata, R. Experience in clinical trials-related SAS programming is preferred.
- You have good presentation and communication skills and are interested in coaching and teaching activities.
- You are able to write and explain study results in a clear, concise and easy to understand English to an audience of non-statisticians.
- You have excellent knowledge of English and French. Knowledge of Dutch is an asset.
- Overseas experience is an advantage.
ITM is an open and international campus where staff, students and researchers work on the new international health challenges. We strive for excellence, integrity, specificity and efficiency. Your assignment contributes to our mission. We value human dignity and diversity, academic creativity and a critical spirit, solidarity and cooperation, and the well-being of employees, students, patients and clients. Together we ensure a pleasant working atmosphere with attention to work-life balance and opportunities for training.
We offer you:
- A fulltime employment for two years, extendable. Starting date as soon as possible.
- A salary according to the scales of the Flemish universities and to your work experience, with supplementary extra-legal benefits: a public transport subscription and/or bicycle fee, private pension scheme and meal vouchers subscription.
For more information contact HR (firstname.lastname@example.org). Please send your CV with your letter of motivation to email@example.com before 21 May 2021.
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