Summary
ThePrincipal Biostatistician Consultant is a delivery focused role whoworks under the leadership oversight and direction of a Programmingteam leader to lead and/or support aspects of the Programmingeffort to deliver technical programming and information componentsof a project. This position requires high technical skills andthorough industry knowledge to independently perform theProgramming tasks.
Main Job Tasksand Responsibilities:
* Responsible for protocol development including studydesign sample size calculation randomization and statisticalanalysis plan for assigned studies.
* Providestatistical oversight to studies and assure adequate quality andconsistency with project requirements.
* Responsible for assuring that data for statisticalanalyses are complete accurate and consistent.
* Responsible for statistical analysis plans and theaccuracy and timeliness of statistical input into reports ordecisions.
* Responsible for validity ofanalysis and explore alternative analysis strategies asneeded.
* Demonstrates extensive understandingof statistical concepts and methodologies. Recognizes and correctsflaws in scientific reasoning and statisticalinterpretation.
* Responsible for accuracy andconsistency of statistical tables figures and data listingsaccuracy of report text and consistency between summary tables inthe body of reports and the corresponding source tables andlistings.
* Responsible for statistical methodssection for the reports. Identifies and corrects common flaws ininterpretation of results inconsistency in presentation orinference adherence to the report guidelines and assuresprojectwide consistency.
* Effectively mentorpeers with regards to statistical methodology and provideappropriate training to less experienced statisticians.
* Manage activities of statisticians across projects byappropriately coordinating assignments and reviewing work so thatprojects are delivered on time with highquality.
Education andExperience:
* MS or PhDin Statistics Biostatistics or related field. PhD with 35 years ofexperience or MS with 68 years of experience.
* Strong oral and written communications skills withability to effectively communicate internally and withclients.
* Demonstrated understanding andinsight in statistics drug development process and relevant FDAregulations.
* Pharmaceutical CRO or relatedindustry experience with clinical trials including interaction withRegulatory Agencies especiallyFDA.
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RemoteWork :
No