Senior Statistical Analyst

2 weeks ago

shimoga, India beBeeStatistical Full time

Job OpportunitySponsor-focused Statistician: Collaborate closely with a pharmaceutical client, backed by Cytel's support.Create SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studiesDevelop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphsDeliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needsParticipate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelinesSupport the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analysesFamiliarize yourself with FDA regulations affecting the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macrosParticipate in the development of CRFs, edit check specifications, and data validation plansProvide review and/or author data transfer specifications for external vendor dataCollaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners) to ensure meeting project timelines and goalsProvide review and/or author SOPs and/or Work Instructions related to statistical programming practices.About the RoleThe ideal candidate will possess:Strong analytical skills and attention to detailExcellent communication and teamwork abilitiesFamiliarity with FDA regulations and clinical trial best practicesWhat We OfferWe provide:A collaborative and supportive work environmentOngoing training and professional development opportunitiesA competitive salary and benefits packageWhy Join UsThis is an exciting opportunity to be part of a dynamic team dedicated to delivering high-quality results in clinical development.

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