- 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 f