Lead Statistical Programmer

2 weeks ago

kannur, India beBeeStatisticalProgrammer Full time

Job OverviewWe are seeking an accomplished statistical programmer to lead clinical development programs across various therapeutic areas. This professional will be responsible for implementing all reporting and analysis activities for Sponsor clinical trials, working closely with pharmaceutical clients.Create SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs.Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs.ResponsibilitiesImplement all reporting and analysis activities for the Sponsor clinical trials.Develop and maintain SAS and/or R programs tailored to clinical development programs' needs.Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies.Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses.Understand and follow FDA regulations which affect the reporting of clinical trial data.Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.Participate in the development of CRFs, edit check specifications, and data validation plans.Provide review and/or author data transfer specifications for external vendor data.Collaborate with internal and external functions to ensure meeting project timelines and goals.Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices.

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