Senior Clinical Data Analyst

3 days ago


Gandhinagar, India beBeeStatistical Full time

Job OverviewGenerate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple clinical studies.Develop SAS programs generating datasets, complex listings, tables (including descriptive and standard inferential statistics) in collaboration with a Statistician, and create graphs.Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development needs.This position requires overseeing CRO deliverables, supporting the preparation of clinical study reports, regulatory submissions, publications, annual safety updates, and exploratory analyses. The ideal candidate will contribute to creating, maintaining, documenting, and validating standards for programming tools, outputs, and macros.The successful candidate should have strong knowledge of SAS programming, CDISC standards, medical terminology, trial methodologies, and FDA/ICH regulations. 7+ years' experience as a Statistical Programmer is required on a Biotech/Pharma Clinical Development team or similar team.Educational Background: Bachelor's degree in Computer Science, Mathematics, Statistics, Engineering or related field is essential.Required Skills: Advanced SAS programming skills, expertise in CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulation. Strong analytical and problem-solving skills are necessary.Benefits: Competitive salary and benefits package, opportunities for professional growth and development, and a dynamic work environment.



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