Principal Statistical Programmer-FSP

Tech Observer, a Global Clinical Research Organization (CRO) & FSP provider that has been supporting the Pharmaceuticals & Life Sciences Industry since 2005. We have offices in New Jersey, US (Headquarters), India, Denmark, UK & Singapore. Through our local partners, we extend our coverage to Australia, China, Malaysia, South Korea, Taiwan, Thailand, Vietnam, and other countries. Job Responsibilities ( But not limited to) Carry out all activities according to Tech Observer/Client SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP). Ensure adherence to programming guidelines. Understanding of Protocol and SAP requirements Lead the assigned project or task Write SAS/R programs for development and QC of SDTM datasets, ADaM datasets and reports (i.e. Tables, Listings and Figures) Write SAS programs for development and QC of Randomization Schedule Development and QC of SDTM and ADaM specifications Development and QC of e-submission package for SDTM and ADaM Review of study documents such as CRF, Metadata, Protocol, SAP and Mockshells Demonstrate excellent problem-solving skills, a proactive approach and a willingness to take decisions on a regular basis. Perform function/project specific responsibilities as assigned Demonstrate quick learning capabilities to improve programming and domain knowledge Provide support in the driving system and process improvements, and to develop and implement solutions to improve efficiency and quality of clinical study data processing and reporting Demonstrate 100% compliance and adherence to all SOPs Prepare and implement standard operating procedures (SOP) Write complex SAS macros Mentor junior statistical programmers and conduct knowledge sharing sessions Website: LinkedIn: #J-18808-Ljbffr Tech Observer