Job Title

LEAD STATISTICAL PROGRAMMER (9 – 11 YEARS)LOCATION: ANYWHERE IN INDIAWORK MODE - HYBRIDROLES and RESPONSIBILITIES: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shellReview Specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages [Define.xml], and Reviewers guide [RGs] for all the deliverables Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shellsSetup the folder structure for the assigned study as per the SOPForecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projectsProvide the study status to the Project Manager/Client periodicallyIdentify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/ClientsMaintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory complianceContribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiencyAdhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelinesProvide guidance, mentoring, and training for junior team members as appropriate.Ensure audit readiness and quality control for all assigned statistical programming deliverables as well as the accuracy and reliability of statistical analysis resultsTo ensure that the assigned team members are in compliance with SOPs and training requirements