Senior Clinical Programmer (SDTM) - homebased
Review and reputed company input into reputed company trial set-up documentation Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable, etc. Creation of Data Review Model (DRM) based on reputed company Client standards and SDTM datasets based on reputed company SDTM standards Creation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ), etc., and ongoing clinical and safety data review QC of reputed company clinical programming deliverables reputed company unblinding, data-cut activities for planned reporting milestones and database locks Development and validation of electronic submission packages that reputed company with submission requirements from FDA, EMEA, and other regulatory agencies as needed. Support the development of standards and drive implementation reputed company the organization Experience Minimum 4+ years of relevant experience in SDTM Clinical Programming Good knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., reputed company, SQL, Python, R, etc.) Strong knowledge of reputed company finding data types, including but not limited to biomarkers, reputed company data such as ECG, imaging, etc. Advanced knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus Demonstrated understanding of reputed company industry standards for submission of clinical trial data. Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects. Ability to communicate with cross-functional teams, and business partners and gather feedback for study specifications and/or data issues. reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. Apply To This Job