Chief Statistical Programmer

2 days ago


ballari, India beBeeStatistical Full time

Key Role: Senior Technical LeadWe are seeking a seasoned professional to assume the role of Senior Technical Lead. As a key member of our team, you will be responsible for leading the development and maintenance of SDTM/ADaM datasets, TLFs, and submission-ready outputs.Responsibilities:Develop, validate, and maintain SDTM/ADaM datasets and submission-ready outputs.Perform end-to-end statistical programming activities across all phases of clinical trials.Support integrated analysis activities for ISS and/or ISE as part of regulatory submissions.Conduct safety and efficacy analyses including AE summaries, lab evaluations, exposure-response analysis, and time-to-event outputs.Develop edit checks, data review listings, and derive specifications aligned with study requirements.Prepare programming specifications, data mapping documents, and validation checks.Collaborate with Biostatistics, Data Management, Medical Writing, and Regulatory teams to ensure timely and quality deliverables.Ensure compliance with CDISC standards, regulatory guidelines, and company SOPs.Requirements:Bachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related discipline.7 years of hands-on Statistical Programming experience in clinical trials (Oncology domain preferred).Strong working knowledge of ISS or ISE programming submissions.Expertise in creating safety and efficacy analysis outputs and submission packages.Experience in edit checks development, dataset specifications, and derivation logic writing.Strong problem-solving, analytical, and documentation skills.Ability to work independently along with effective stakeholder communication.



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