Senior Technical Lead

2 weeks ago


alappuzha, India beBeeTechnical Full time

Technical Leadership RoleWe are seeking a seasoned technical lead to drive statistical programming activities in Oncology clinical trials. As a senior expert, you will be responsible for developing and maintaining SDTM/ADaM datasets, TLFs (Tables, Listings & Figures), and submission-ready outputs.Develop, validate, and maintain datasets according to CDISC standards.Perform end-to-end statistical programming activities across all phases of clinical trials.Support integrated analysis activities for 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 cross-functional teams to ensure timely and quality deliverables.RequirementsBachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related field.7+ years of hands-on Statistical Programming experience in clinical trials (Oncology domain preferred).Strong 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 and communicate effectively with stakeholders.



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