Clinical Trial Data Developer

6 days ago


kochi, India beBeeStatistical Full time

Job OpportunityWe are seeking an experienced Statistical Programmer Leader to support the development of clinical trial datasets and statistical programming deliverables.Key Responsibilities:Develop, validate, and maintain clinical trial datasets using SAS and R programming languages.Lead the full spectrum of statistical programming deliverables, including creation and review of SDTM and ADaM specifications, development of SDTM and ADaM datasets, TLF (Tables, Listings, Figures) programming, and preparation of Define.xml and reviewer's guides.Work independently with minimal oversight, ensuring timely and high-quality deliverables.Communicate proactively with internal teams, providing clear updates and technical guidance.Required Qualifications:Prior experience working in global or geographically distributed teams.In-depth knowledge of CDISC standards and regulatory submission requirements.Experience supporting FDA and PMDA submissions.Ability to manage multiple studies simultaneously and prioritize tasks effectively.Strong documentation, planning, and organizational skills.Benefits:Opportunity to work on various clinical trials and contribute to the development of new therapeutic products.Chance to collaborate with cross-functional teams and develop leadership skills.Professional growth and development opportunities.Additional Information:Must be able to work independently and as part of a team.Excellent communication and problem-solving skills required.


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