Senior Biostatistician

The OpportunityWe are seeking an experienced, high caliber Senior Biostatistician to join Abbott’s medical device clinical research organization. This position includes providing statistical expertise in clinical study design, writing statistical analysis plans and reports, performing statistical analysis and programming, checking data quality, preparing analysis datasets, generating and/or validating data listing, and tables/reports. This position will also assist on additional study projects or tasks which may arise.Job Duties:Provide statistical input into clinical study design, endpoints, hypotheses tests and sample size calculationsWrite statistical sections of protocolsWrite statistical analysis plansProvide input into data collection forms (Case Report Forms) and data management planProvide input on study processes, especially those affecting scientific integrity and data qualityWrite or provide input into Data Monitoring Committee (DMC) and/or Clinical Events Committee (CEC) charterEnsure scientific integrity and data quality of clinical trials are preservedParticipate in DMC meetings as appropriatePrepare statistical reports or statistical sections of clinical study reportsInterpret statistical resultsGenerate line listings for regulatory reporting as appropriatePerform validation of statistical analyses conducted by statistical peers or colleaguesEnsures accuracy of report text and consistency between summary tables in the body of reports and the corresponding statistical tables and listings.Responsible for statistical methods-Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, and adherence to Abbott report guidelines.Provides meaningful input to the development of a report strategy.Works collaboratively with peers to develop quality protocols, CRF, schema, and reports per agreed timelines.Provides accurate and timely answers to routine questions from clients, scientific insight when answering nonstandard questions, and independently pursues analyses suggested by the data.Communicates an understanding of basic clinical principles for his/her project and acts in accordance with those principles.Can clearly communicate basic statistical concepts to other scientists and nonscientists. Informs supervisor or manager on important issues in a timely manner.Required QualificationsMasters in statistics or biostatistics with a minimum of five plus years of experience or Ph.D. in statistics or biostatistics.Able to write/describe statistical models of moderate complexity.Experience with SAS is required; experience with R, Winbugs, JMP, NCSS PASS and other statistical software are a plus.Knowledge of Bayesian and/or adaptive design methods and data mining are a plus.Preferred qualifications:Experience in medical device Clinical Research role is preferred.

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