Technical Lead for Clinical Trials

7 days ago

kakinada, India beBeeStatistical Full time

Job OverviewAs a seasoned technical leader, you will be responsible for overseeing the development and maintenance of SDTM/ADaM datasets, TLFs (Tables, Listings & Figures), and submission-ready outputs across various phases of Oncology clinical trials.Key ResponsibilitiesDevelop and Validate Datasets: Create, validate, and maintain high-quality SDTM/ADaM datasets, TLFs, and submission-ready outputs in accordance with regulatory requirements and company standards.Statistical Programming Activities: Perform end-to-end statistical programming activities across all phases of Oncology clinical trials, ensuring timely and accurate results.Integrated Analysis Support: Collaborate with Biostatistics, Data Management, Medical Writing, and Regulatory teams to support integrated analysis activities for ISS and/or ISE as part of regulatory submissions.Safety and Efficacy Analyses: Conduct safety and efficacy analyses, including AE summaries, lab evaluations, exposure-response analysis, and time-to-event outputs, to support regulatory submissions.Edit Checks and Specifications: Develop edit checks, data review listings, and derive specifications aligned with study requirements to ensure compliance and quality.Programming Specifications and Validation: Prepare programming specifications, data mapping documents, and validation checks to ensure seamless integration and execution.Required Qualifications and SkillsEducation: Bachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related discipline.Experience: 7 years of hands-on Statistical Programming experience in clinical trials, preferably in the Oncology domain.Skills: 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.Soft Skills: Strong problem-solving, analytical, and documentation skills, ability to work independently, and effective stakeholder communication.BenefitsThe ideal candidate will have the opportunity to work on complex projects, collaborate with cross-functional teams, and contribute to the success of our organization.

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