Senior Technical Lead - Statistical Programming ( Oncology )

Description -

• Develop, validate, and maintain SDTM / ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs.
• 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.
• 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 :