Technical Lead

2 days ago

kottayam, India beBeeStatistical Full time

Job DescriptionAs a Senior Technical Lead in our company, you will play a pivotal role in driving the development and implementation of statistical programming solutions for Oncology clinical trials. You will be responsible for creating, validating, and maintaining SDTM/ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs.You will perform end-to-end statistical programming activities across all phases of Oncology clinical trials, including developing edit checks, data review listings, and deriving specifications aligned with study requirements. Additionally, you will prepare programming specifications, data mapping documents, and validation checks.Collaboration with Biostatistics, Data Management, Medical Writing and Regulatory teams is essential to ensure timely and quality deliverables. Your expertise in creating safety and efficacy analysis outputs and submission packages will be highly valued.Required Skills and QualificationsBachelor'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.Key ResponsibilitiesDevelop, 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.What We OfferWe are committed to fostering a collaborative and dynamic work environment that encourages growth and professional development. As a Senior Technical Lead, you will have the opportunity to work on challenging projects, develop your skills, and contribute to the success of our team.

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