- Gives input into the study design, efficacy and safety parameters and the planned statistical analyses. Performs simulations to support choice of study design, decision rules and the sample size. Participates in protocol development, if this is not delegated to an external partner (hereinafter "EP"), otherwise reviews and approves prepared protocol
- Supports or oversees EP biostatistical support for all statistical operational aspects of the clinical trial, covering trial set up, trial delivery and the readout of results. This includes input into randomization specifications, statistical analysis plans, interim analyses, safety reviews and final analyses.
- Communicates and coordinates all statistical activities with EP biostatisticians. Ensuring the implementation of global, program and SSI standards by all biostatisticians contributing to the project.
- Provides input on interpretation of results by attending and presenting at the Results Interpretation Meeting (RIM). Reviews and inputs into the clinical study report.
- Assists the Project Lead Statistician with the statistical deliverables for regulatory submissions and the lifecycle of a development compound.
- Master degree in statistics with background in mathematics/statistics, PhD in statistics is a plus
- Good knowledge of multivariate analysis (regression analysis, ANOVA, PCA, PLS) and mixed models is required
- Good knowledge in statistical process control and experimental designs is an asset.
- Proficiency with R and SAS (base, stat) is expected. Other statistical packages knowledge is an asset (JMP, …).
- Some background in Pharmaceutical/Bilogical R&D and Manufacturing.
- Experience in multidisciplinary projects.
- Fluent English is required, French is a plus.
representation fee, company car with fuel card (unlimited for professional and personal purposes); mobile phone; meal vouchers, health insurance, insurance for pension