Clinical Development Statistical Programmer

2 weeks ago


tiruppur, India beBeeStatistical Full time

Job Opportunity:We are seeking a skilled Statistical Programmer to join our team. In this role, you will be responsible for generating SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies. Your expertise in SAS programming will also be utilized to develop programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs.As a Statistical Programmer, your responsibilities will include:Developing and implementing statistical programming procedures and processes in a clinical development environmentGenerating high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needsParticipating in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelinesSupporting the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analysesUnderstanding and following FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.



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