DirecciónJob Description
Senior Statistician is an integral part of our team here at PSI. If you have experience in clinical research, understand SAS programming principles and concepts, and have a good knowledge of statistical methods, apply today!
You will :
- Lead all biostatistics activities related to clinical trials as responsible project statistician
- Communicate with project teams, clients and vendors on statistical questions
- Develop and review statistical sections of protocols, including sample size calculations
- Develop statistical analysis plans
- Develop and document analysis database structures (i.e. SAS analysis data set structures)
- Develop SAS program requirements and specifications
- SAS programming and program validation
- Review and QC of statistical deliverables (tables, listings, figures, etc.)
- Perform statistical analysis and report results
- Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products
- Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics
- Participate in bid defense meetings and kick-off meetings
- Train statisticians and SAS programmers
- Prepare and deliver presentations at investigators' meetings
- Address audits findings / recommendations, and follow-up on and resolution of audit findings
- Participate in the development of guidelines, procedures
Qualifications
- MSc in Statistics or equivalent
- Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
- Knowledge and understanding of the SAS programming language; advanced knowledge of SAS software
- Ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
- Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
- Strong knowledge of CDISC ADaM
- Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
- Presentation and communication skills
Hace más de 30 días
