Senior Biostatistician

We are looking for a Senior Biostatistician to provide statistical expertise and support in the development of medicines. You will be located at the Headquarters in Belgium (Leuven) and will report to the Head of Clinical Ophthalmology.

• Providing statistical expertise to support the different departments such as Clinical Development, Medical Affairs, Health Economics, …
• Defending statistical positions in interaction with regulatory authorities
• Managing external providers for the preparation of statistical outputs and summary reports
• Reviewing materials to support regulatory submission
• Create statistical sections for study synopses and protocols
• Advising on the methodological correctness and efficiency of the study design
• Preparing statistical analysis plan
• SAS programming (limited)
• Datamining
• MSc or PhD in Statistics or Biostatistics
• Minimum five years of experience as a Biostatistician supporting pharmaceutical clinical trials and clinical development
• Wide experience with SAS programming required
• Knowledge of ICH/GCP guidelines
• Previous experience with submissions to FDA and/or European authorities
• Thorough understanding of statistical issues in clinical trials