- 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.
- 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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Principal Biostatistician Consultant - London, United Kingdom - Lifelancer
Description
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:
Education andExperience:
Please use the below link forjob application and quickerresponse.
RemoteWork :
No