Technical Director

2 weeks ago

solapur, India beBeeStatistical Full time

Job OverviewThis Senior Technical Lead position is focused on delivering high-quality statistical programming outputs for Oncology clinical trials.We are seeking a skilled professional with expertise in creating safety and efficacy analysis outputs, submission packages, and edit checks development. The ideal candidate will have strong working knowledge of ISS or ISE programming submissions and experience in dataset specifications and derivation logic writing.The role requires collaboration with cross-functional teams to ensure timely and quality deliverables. Strong problem-solving, analytical, and documentation skills are essential for success in this position.Main Responsibilities:Develop SDTM/ADaM datasets, 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.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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