Statistical Programmer
17 hours ago
Data Analysis: Collaborate with cross -functional teams to perform data analysis for phase I to IV clinical studies. Implement statistical programming solutions to support these studies effectively.Data Review: Review electronic Case Report Forms (eCRF) and engage in discussions about data structures.Ensure that data review activities adhere to company, department, and industry standards (e.g., CDISC).Professionalism and Training: Maintain a high level of professionalism, performance, productivity, and quality. Undergo Regulatory trainings, including ICH GCP and 21 CFR Part 11 trainings, to stay updated with industry standards. Study Documents and Training: Read and understand the Study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells, etc.). Complete Project Specific Trainings and maintain appropriate documentation.Data Annotation and Review: Annotate eCRF using Dataset specifications and create annotated CRF (aCRF). Review CRF annotations for protocol compliance and data consistency.Programming and Data Management: Develop user -specific Edit check programs to ensure data quality. Identify and document data issues through appropriate trackers and report to the Lead Programmer. Develop SAS programs/macros, templates, and utilities for data cleaning and reporting when necessary. Perform Reconciliation of External data.Dataset Development: Develop CDISC compliant datasets (SDTM/ADaM) using the Dataset specifications. Create Annotated Mock shells if required. Develop tables, listings, and graphs using Mock shells.Quality Control and Compliance: Be responsible for all Statistical Programming activities, including Self -Validation checklists. Ensure that all tabulation/analysis datasets are compliant with CDISC/client standards. Verify the compliance of all programs with SOPs and project -specific guidelines. Perform First Time Quality Control on reports created.Communication and Collaboration: Provide SAS programming support for Data Management when required. Communicate effectively with the Lead Programmer regarding daily assigned tasks and study -related questions. Maintain clear and proactive communication with project teams to clarify requirements and specifications.Mentorship and Development: Support junior programmers working on the project and assist in their training requirements. Actively engage in self -learning and development in department -specific skill sets.Regulatory Compliance and Audits: Support/assist in audit -specific requirements for internal/external audits. Ensure that all activities are performed in accordance with GCP -ICH guidelines.Other Responsibilities: Contribute to process improvement initiatives. Provide advanced technical expertise and work under minimal supervision to support various programming activities. Forecast work for the team and provide a vision of ongoing project objectives/milestones. Perform other duties as assigned by the Line Manager/HOD.All your contributions will be carried out in strict accordance with GCP -ICH guidelines, reaffirming our commitment to quality and regulatory compliance in every endeavour. RequirementsEducational Background: Bachelor's, Master's, or international equivalent degree in statistics, computer science, mathematics, life sciences, or a related field.
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