RESPONSIBILITIES: · Perform all programming tasks required to support Data Management and Biostatistics, as necessary. · Perform validation and QC/QA of CDISC, SDTM domain output in accordance with SOPs, SOIs, and guidance documents. · Manage external vendors and ensure accurate and high-quality deliverables. · Ensure documentation and consistent maintenance of code, logs and output within a regulated computing environment. · Create and maintain specifications as per CDISC SDTMIG. · Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams. · Develop, implement and maintain SAS programming standards and performs quality checks. · Review annotated case report forms and database structures. · Develop reports & graphs in Spotfire for easier data review and visualization. This includes developing programs for patient profiles on an ad hoc basis to support the Biostatistics, Data Management, and clinical teams. · Mentor and train other associates within Data Management, as necessary. · Participates in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines. · Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems. · Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies. · Review deliverables before transfer to either internal or external clients ensuring quality.
QUALIFICATIONS： 1. Bachelor's Degree is required, master's Degree is prefered. 2. Minimum of 1 years (w/B.S.) or 4 years (M.S.) SAS and clinical programming experience in the biotech/pharmaceutical/CRO industry. 3. Project management and team leadership experience. 4. Knowledge of CDISC, CDASH and SDTM is a must. 5. Knowledge of reporting tools: Spotfire and JReview are preferred. 6. Experience with programming development, validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission is required. 7. Proficient in industry standards, medical terminology, and clinical trial methodologies.
