Contribute to data and reporting activities for clinical studies or project level activities by creating a program to generate deliverables in accordance with requirements, programming instructions and programming dataset specifications. Create standard, study, project or global macros. Contribute to the development and review programming dataset specifications. Ensure timely and quality development and validation of datasets and outputs (datasets, tables, figures and listings) for study-documents according to specifications. Manage multiple tasks effectively to meet delivery timelines. Seek solutions to programming issues and escalate as needed. Establish and maintain working relationships with team members of assigned studies or project-level activities. Effectively communicate the status of deliverables and any risks to Trial Data Manager and supervisor. Build and maintain effective working relationship with cross-functional team. Comply with company, department and industry standards (e.g. CDISC) and processes, create /support the review of programming specifications as part of the analysis plans. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. Under minimal guidance participates in establishing successful working relationship on individual studies with external associates according to agreed contract and internal business guidance Contribute to assigned parts of process improvement, standardization and other non-clinical initiatives.

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