Oncology Clinical Trials Expert

5 days ago

aligarh, India beBeeTechnical Full time

Job TitleSenior Technical Lead: Oncology Clinical Trials ExpertJob DescriptionWe are seeking a highly skilled Senior Technical Lead to join our team in the field of Oncology Clinical Trials. As a key member of our team, you will be responsible for developing and maintaining SDTM/ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs.You will perform end-to-end statistical programming activities across all phases of Oncology clinical trials, including integrated analysis activities for ISS and/or ISE as part of regulatory submissions.Responsibilities include conducting safety and efficacy analyses, including AE summaries, lab evaluations, exposure-response analysis, and time-to-event outputs.You will develop edit checks, data review listings, and derive specifications aligned with study requirements, prepare programming specifications, data mapping documents, and validation checks.This is an exciting opportunity for a talented individual to collaborate with Biostatistics, Data Management, Medical Writing and Regulatory teams to ensure timely and quality deliverables.The successful candidate will have a strong working knowledge of CDISC standards, regulatory guidelines, and company SOPs, and will support automation, process optimization, and QC initiatives for continuous improvement.Required Skills and QualificationsTo be considered for this role, you will need:Bachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics or a related discipline7 years of hands-on Statistical Programming experience in clinical trials (Oncology domain preferred)Strong working knowledge of ISS or ISE programming submissionsExpertise in creating safety and efficacy analysis outputs and submission packagesExperience in edit checks development, dataset specifications and derivation logic writingStrong problem-solving, analytical and documentation skillsAbility to work independently along with effective stakeholder communicationBenefitsAs a valued member of our team, you can expect:A competitive salary and benefits packageOpportunities for professional growth and developmentA dynamic and supportive work environment

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