The Biostatistician we're looking for would be responsible for a whole study from design to execution for different study designs:
Use statistical methodology to establish study strategy (e.g. power modelling of different scenario, set up power).
Monitoring, set up mitigation plan to minimize risk of stat failure.
Provide input to protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis).
Provide input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation).
Develop Statistical Analysis Plan/Additional Analysis Request (involving sensitivity analysis to support robustness of result) and coordinate review.
Review the Tables Figures and Listings (TFL), to coordinate review with the stat analyst, to approve the TFL.
Do the QC of the statistical analysis methodology.
Validate study specific dataset & analysis programming specification.
Approve deviation from TFL format.
Propose Statistical Analysis Results conclusion.
Prepare answer to study specific stat question (e.g. inspection, regulatory question).
You have 3 to 5 years’ experience in the field of Biostatistics in a pharmaceutical/Contract Research Organization environment.
You are familiar with SAS software.
You have a strong knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, ...).
You have good interpersonal skills and a good global vision of the study process, which allows you to ensure an efficient interface with the project teams (project leader, data managers, medical writers,) and other external stakeholders (scientific experts, methodologists, etc.).
A good knowledge of CDISC standards (ADAM) is a plus.
Fluent in English
Must be a portuguese or european citizen or have a work permit for Portugal