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 Mock shells
• 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

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