Senior Statistician
About The Position
In this role, you will lead all biostatistics activities related to clinical trials as responsible project statistician. You will communicate with project teams, clients and vendors on statistical questions, develop and review statistical sections of protocols, including sample size calculations, and develop statistical analysis plans. You will also develop and document analysis database structures (i.e. SAS analysis data set structures), develop SAS program requirements and specifications, and perform SAS programming and program validation. Additionally, you will review and QC of statistical deliverables (tables, listings, figures, etc.), perform statistical analysis and report results, and consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products. You will 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, and prepare and deliver presentations at investigators' meetings. You will also address audit findings/recommendations, and follow-up on and resolution of audit findings.
Requirements
- MSc in Statistics or equivalent
- Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
- 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
- Expert knowledge and understanding of the SAS programming
- Expert knowledge and understanding of CDISC ADaM standard
- Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
- Ability to work in English
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
