Lead Statistician

Senior Technical Lead - Clinical TrialsDescription:Our organization seeks an accomplished Senior Technical Lead to spearhead statistical programming activities across the lifecycle of Oncology clinical trials. As a key member of our team, you will be responsible for designing, developing, and maintaining high-quality datasets, TLFs (Tables, Listings & Figures), and submission-ready outputs.Develop and validate SDTM/ADaM datasets and submission-ready outputs.Perform end-to-end statistical programming tasks, encompassing all phases of Oncology clinical trials.Collaborate with Biostatistics, Data Management, Medical Writing, and Regulatory teams to ensure timely and quality deliverables.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.Required Skills and Qualifications:For this position, we are seeking candidates with a Bachelor's or Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related discipline. A minimum of 7 years of hands-on experience in Statistical Programming is required, preferably in the Oncology domain. Strong working knowledge of ISS or ISE programming submissions is essential, along with expertise in creating safety and efficacy analysis outputs and submission packages. Additionally, experience in edit checks development, dataset specifications, and derivation logic writing is highly valued.Benefits:As a Senior Technical Lead, you will have opportunities for professional growth and development within our organization. You will work collaboratively with cross-functional teams to drive innovation and excellence in statistical programming.