Senior Statistical Lead

4 days ago


thoothukudi, India beBeeStatisticalLead Full time

Job SummaryWe are seeking a highly skilled Senior Statistical Lead to oversee the development, validation, and maintenance of SDTM/ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs.This role will perform end-to-end statistical programming activities across all phases of Oncology clinical trials.The ideal candidate will support 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.A strong working knowledge of edit checks development, dataset specifications and derivation logic writing is required.The successful candidate will collaborate with Biostatistics, Data Management, Medical Writing and Regulatory teams to ensure timely and quality deliverables.Maintenance of compliance with CDISC standards, regulatory guidelines and company SOPs is also expected.This role will provide support in automation, process optimization, and QC initiatives for continuous improvement.Required Qualifications & SkillsBachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics or a related discipline.7 years of hands-on 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.Problem-solving, analytical and documentation skills are essential.Ability to work independently along with effective stakeholder communication.


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