Lead Statistical Programmer

2 weeks ago

thiruvananthapuram, India beBeeStatistical Full time

Key Roles and Responsibilities:This is an exciting time to be part of our innovative program, where you will be responsible for implementing all reporting and analysis activities for multiple clinical trials.Develop SDTM, ADaM specifications, datasets, reviewer's guide and define.xml filesGenerate high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to the needs of clinical development programsParticipate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-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 the reporting of clinical trial data, including good clinical practice and guidelines for electronic submissionsContribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macrosCollaborate with internal and external functions to ensure meeting project timelines and goalsRequired Skills and Qualifications:Experience with generating complex listings, tables, and graphs using SAS or RStrong understanding of statistical programming principles and practicesExcellent analytical, problem-solving, and communication skillsAbility to work independently and collaboratively as a team memberKnowledge of FDA regulations and guidelines related to clinical trial data reportingBenefits:Opportunity to work on cutting-edge projects and develop new skillsCollaborative and dynamic work environmentCompetitive compensation and benefits packageProfessional growth and development opportunities

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