Biostatistician

3 weeks ago

Delhi, India Capgemini Engineering Full time

NOTE- This job requires you to work from Capgemini Office(Pan India).JOB DESCRIPTIONThe Senior Statistician collaborates with Biostatisticians, Statistical Programmers, Clinical Data Managers, Clinical Research Associates, and sponsors’ teams to provide high-quality, reliable statistical expertise and support.Additionally. they perform and oversee quality control (QC) of data displays with inferential statistics. Also, Senior Statistician conduct QC analysis datasets prepared by others, maintain project administration files (including protocols, annotated CRFs, statistical analysis plans, annotated shells, programming/QC rules, tracking logs, and project communications),QUALIFICATIONS FOR ESSENTIAL FUNCTIONSLooking for 10+yrs of experienceStatistical leadership and support to clinical trials.Participate in cross-functional study-related activities and team meetingsPerform sample size calculations when neededAuthor or review statistical analysis plansCoordinate with other biostatisticians, statistical programmers and data managers to prepare/conduct/review statistical analyses.Ensure the accuracy of final statistical deliverables.Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures.Perform validation of analysis variables and statistical outputsParticipate in other activities and meetings to support Biostatistics and the Development Team as needed.EDUCATION AND EXPERIENCE REQUIREDMaster’s degree in statistics or related fields with 6+ years of industry experiences as a StatisticianPhD degree with 3+ years of postgraduate experiences in Biostatistics or equivalent.Ability to lead project and manage team members and work collaboratively, effectively, and productively in diverse organization structures.Solid statistics background and training, working knowledge of advanced statistical methodologies and SAS programming skills; good understanding of drug development and experiences with clinical trial data analyses/preparation for submissions; good knowledge and understanding of regulatory guidelines

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