We are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight.
Department responsibilities include specification, development, quality validation and regulatory submission compliance adherence for PPD developed CDISC SDTM and CDISC eCRT (Define.xml) programming deliverables. In addition deploys Spotfire dashboards, Safety notification and reporting for Medical Monitor review and regulatory actions. Acts as a key team member for internal Biostat interactions and client engagement on CDISC submission topics, or internal contact for procedural and technical initiatives. Ensures effective delivery across all project requirements including communicating priorities and work direction to complete assigned tasks on time and within budget. Participates in client and department wide engagement on CDISC solutions, integrations and submissions.