Senior Biostatistician (m/f/x)
In this position you will lead all biostatistics activities related to clinical trials. You will be responsible project statistician and liaise with DM on statistical questions related to data issues, including coordination of data transfers from DMs to statistics. You will also address audits findings and follow up and resolve audit findings.
What will your tasks be as ´Senior Biostatistician´?
* Develop and document analysis database structures (i.e. SAS analysis data set structures)
* Develop SAS program requirements and specifications
* SAS programming and program validation
* Lead all biostatistics activities related to clinical trials as responsible project statistician
* Participate in the development of guidelines, procedures
* Review and QC of statistical deliverables (tables, listings, figures, etc.)
* Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products.
* Train statisticians and SAS programmers
* Prepare and deliver presentations at investigator's meetings
* Participate in bid defence meetings and kick-off meetings
* Participate in the development of guidelines, procedures
* Develop statistical analysis plans
Your Requirements as ´Senior Biostatistician´?
* MSc in Statistics or equivalent
* Knowledge and understanding of the SAS programming language; advanced knowledge of SAS software
* Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
* Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
* Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
* Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
* Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
* 4+ years of experience.
