Senior Statistical Analyst

3 days ago

madurai, India beBeeBiostatistical Full time

Lead Biostatistical ProgrammerThis is an exciting opportunity to work fully embedded within a pharmaceutical client, supported by our team behind you.You will report to the Director, Biostatistics and Programming in our company's business unit.Job Overview:The Lead Biostatistical Programmer works independently with minimal supervision; tracks progress and provides expert technical support to colleagues.We are looking for a highly experienced senior biostatistical programmer who will work on clinical development programs across various therapeutic areas and oversee CRO programmers to ensure high-quality data summaries are delivered consistently.Develop SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studiesCreate SAS programs generating datasets, complex listings, tables (including descriptive and standard inferential statistics in collaboration with a Statistician), and graphsDeliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needsOversee CRO's statistical programming deliverables for multiple clinical studies to ensure quality and meet pre-specified timelinesSupport the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analysesUnderstand and follow FDA regulations affecting clinical trial data reporting, including good clinical practice and guidelines for electronic submissionsContribute to creating, maintaining, documenting, and validating standards for programming tools, outputs, and macrosParticipate in developing CRFs, edit check specifications, and data validation plansReview and/or author data transfer specifications for external vendor dataCollaborate with internal and external functions to ensure meeting project timelines and goalsReview and/or author SOPs and/or Work Instructions related to statistical programming practicesRequirements:Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studiesDevelop SAS programs generating datasets, complex listings, tables and graphsDeliver high-quality statistical programming resultsOversee CRO's statistical programming deliverablesUnderstand FDA regulations affecting clinical trial data reportingBenefits:Highly competitive compensation packageComprehensive benefits including medical, dental, and vision coverageGenerous retirement planOpportunities for professional growth and developmentWhat We Offer:Our company offers a dynamic and supportive work environment. We provide opportunities for professional growth and development through training and mentorship programs.We prioritize employee well-being and offer flexible work arrangements and a comprehensive benefits package.Join our team of talented professionals and contribute to the success of our clients.

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