- MS, Biological & Biomedical Sciences OR
MS, Mathematics & Statistics
- 2 years of experience in biostatistics applied to epidemiology OR 4 years of experience in biostatistics applied to clinical research or similar fields
- Experience working with vaccines
- Excellent communication skill in a multifunctional and multicultural environment
- Experience with CDISC data format (SDTM and ADAM)
- Good programming skills in SAS
Senior Biostatistician in Epidemiology provides full statistical expertise to support the different observational study designs
- Responsible for a whole study from design to execution for different study designs:
- Defines the correct stat methodology and study design (case-control, cross-sectional, cohort, Self-controlled Case-series, etc...)
- Provides input to protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis)
- Provides input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation, specific cleaning)
- Develops SAP/AAR (involving sensitivity analysis to support robustness of result) and coordinate review
- Reviews the TFL, to coordinate review with the stat analyst, to approve the TFL
- Performs the QC of the statistical analysis
- Validates study specific dataset & analysis pgm specification
- Approves deviation from TFL format
- Proposes conclusions of the statistical analysis
- Prepares answers to study specific stat question (eg inspection, RA question)
- Provides stat support to an independent analysis center
- Provides consultancy on stat matter for other statisticians
- Participates in publication writing
You may apply for this position online by selecting the Apply now button.
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