LEAD STATISTICAL PROGRAMMER

2 weeks ago


bangalore, India ACL Digital Full time

LEAD STATISTICAL PROGRAMMER (9 – 11 YEARS) LOCATION: ANYWHERE IN INDIA WORK MODE - HYBRID ROLES and RESPONSIBILITIES: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Review 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 shells Setup the folder structure for the assigned study as per the SOP Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects Provide the study status to the Project Manager/Client periodically Identify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/Clients Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines Provide 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 results To ensure that the assigned team members are in compliance with SOPs and training requirements



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