In-depth critical and quality review of key documents and deliverables, ensure and maintain internal quality documentation; Plan, lead and perform internal quality review efforts of statistical programming study deliverables ; Critically evaluate management of operational and data risks within the cross-functional study team ; Preparation and quality review of regulatory submission packages

» Create and participate in the development and review of specification documents for data transformation into the appropriate data models» Prepare summarized information (data and TLGs) for clinical study team members» Lead statistical programming activities at study level or part of clinical project» Assess and clarify requirements, contribute to developing programming specifications, providing statistical programming solutions and ensure their efficient implementations» Responsible for accuracy and reliability of results» Build and maintain effective working relationships with cross-functional teams» Negotiate alternative timelines based on resources or priority constraints» Negotiate effectively with CROs for reasonable timelines and scope