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Principal Biostatistician Consultant

2 months ago

London, United Kingdom Lifelancer Full time

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.

Please use the below link forjob application and quickerresponse.

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