Lead Statistician

5 days ago


moradabad, India beBeeSenior Full time

We are seeking a highly skilled Senior Technical Lead to contribute to our organization.As a key team member, you will be responsible for developing, 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, supporting integrated analysis activities for ISS and/or ISE as part of regulatory submissions.Your responsibilities will include conducting safety and efficacy analyses including AE summaries, lab evaluations, exposure-response analysis, and time-to-event outputs.You will also develop edit checks, data review listings, and derive specifications aligned with study requirements, prepare programming specifications, data mapping documents, and validation checks.A collaborative environment is essential for this role, as you will work closely with Biostatistics, Data Management, Medical Writing and Regulatory teams to ensure timely and quality deliverables.The ideal candidate will have a Bachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related discipline, and 7 years of hands-on Statistical Programming experience in clinical trials (Oncology domain preferred).Key skills required for this role include 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, and ability to work independently along with effective stakeholder communication.