Expert Biostatistician, Epidemiology
Rockville , Maryland
December 17, 2017
Basic qualifications:
-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

Preferred qualifications:
-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

Contact information:

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