Senior Statistical Programming Lead

1 week ago

udaipur, India beBeeData Full time

Statistical Programming LeadWe are seeking a skilled Statistical Programming Lead to join our team. As a key member of our clinical trials group, you will be responsible for developing, validating and maintaining SDTM/ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs.Develop high-quality statistical programming specifications, data mapping documents, and validation checks to ensure timely and accurate deliverables.Collaborate with Biostatistics, Data Management, Medical Writing, and Regulatory teams to ensure quality and compliance with regulatory guidelines and company SOPs.Key Responsibilities:Perform end-to-end statistical programming activities across all phases of Oncology 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.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.

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