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Senior Technical Lead - Statistical Programming ( Oncology )
Senior Technical Lead - Statistical Programming ( Oncology )Ephicacy • ranchi, jharkhand, in
Senior Technical Lead - Statistical Programming ( Oncology )

Senior Technical Lead - Statistical Programming ( Oncology )

Ephicacy • ranchi, jharkhand, in
4 hours ago
Job description

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 :

  • 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.
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    Senior Technical Lead • ranchi, jharkhand, in

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