Senior Statistical Lead

2 days ago

vijayawada, India beBeeStatistical Full time

Job Title:Senior Statistical Lead - Oncology Clinical TrialsWe are seeking an experienced Senior Statistical Lead to lead the development and delivery of high-quality statistical programming deliverables for Oncology clinical trials.We require a strong background in ISS or ISE programming submissions, with expertise in creating safety and efficacy analysis outputs and submission packages.Key responsibilities include developing, validating, 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, ensuring 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 data review listings, edit checks development, dataset specifications, and derivation logic writing.Excellent problem-solving, analytical, and documentation skills.About this role:As a Senior Statistical Lead, you will work collaboratively with Biostatistics, Data Management, Medical Writing, and Regulatory teams to ensure timely and quality deliverables. You will also contribute to process optimization and QC initiatives for continuous improvement.

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