Clinical DM SAS Programmer

Project Role: Clinical Data Management SAS Programmer

Work Experience: 5+ Years

Work location: Any IQVIA office Location In India

Work Mode: Hybrid

Must Have Skills: Clinical SAS/DM SAS/SAS Macros

Note : this position is not for Statistical programming

Job Description

• Works collaboratively within Biometrics assisting in providing support to Clinical Data Management activities.
• Works collaboratively with Statistical Programmer, Clinical Data Manager, Biostatistician, Global Drug Safety, Regulatory and Project Management staff and vendors to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
• Ensures completeness, correctness and consistency of clinical data and data structure.
• Provides timely support to the study team on all programming matters according to the project plan and programming specification using internal standards and guidelines.
• Provides input on clinical data validation specifications and data transfer specifications.
• Contributes to the reporting of routine clinical data through regulatory approval, product launch and annual reports.
• Contributes to the monitoring of data quality during study conduct, providing information on issues along with proposed solutions.
• Ensures completeness, correctness and consistency of clinical data and data structure.
• Acts as Study Clinical Programmer
• Reviews and accepts work by supporting Clinical Programmer
• Attend Study Meeting Team to provide inputs as needed.
• Provides guidance to timeline for deliverables.
• Performs extract, map, transform, and load of clinical data.
• Generates edit checks, listings and reports.
• Performs study tasks.

Requires a minimum of Bachelor’s degree in Mathematics (or equivalent) / Computer Science.

• Excellent verbal and written communication skills and interpersonal skills are required.
• Working understanding of pharmaceutical clinical development and ability to provide programming support for NDA and other regulatory submissions.
• Working understanding of statistical concepts and techniques is expected.
• Working understanding of development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required
• Working knowledge of FDA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) and clinical data management systems is also required.
• Working knowledge of clinical study is required and biomarker data is preferred.