Senior Statistical Programmer Lead

4 days ago

tiruchirappalli, India beBeeStatistical Full time

Job Summary:We are seeking a seasoned professional to lead our statistical programming activities across all phases of Oncology clinical trials. The ideal candidate will possess strong expertise in creating safety and efficacy analysis outputs and submission packages.Key Responsibilities:Develop, validate, and maintain SDTM/ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs.Perform end-to-end statistical programming activities for 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.Develop edit checks, data review listings, and derive specifications aligned with study requirements.Prepare programming specifications, data mapping documents, and validation checks.Collaborate with Biostatistics, Data Management, Medical Writing and Regulatory teams to ensure timely and quality deliverables.Ensure compliance with CDISC standards, regulatory guidelines and company SOPs.Support automation, process optimization, and QC initiatives for continuous improvement.Required Qualifications & Skills: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.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 along with effective stakeholder communication.About the Role:This is an exciting opportunity for a skilled statistician to join our team and make a meaningful contribution to the success of our Oncology clinical trials.

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