SAS Developer

IQVIA India; Bengaluru; Hybrid; INR 900,000 - 1,500,000; Full time

Job summary

IQVIA India is seeking a Clinical SAS/DM Programmer to support Clinical Data Management activities within Biometrics. You will collaborate with the Statistical Programmer, Clinical Data Manager and Regulatory teams to ensure timely data delivery, quality checks and regulatory-ready reporting.

The role requires a Bachelor’s degree in Mathematics or Computer Science, strong communication skills, and knowledge of FDA 21 CFR Part 11 and EDC systems. Hybrid work arrangement in India is offered.

Qualifications

• Excellent communication and interpersonal skills.
• Understanding of pharmaceutical clinical development and NDA/regulatory submissions.
• Knowledge of FDA regulations (21 CFR Part 11) and EDC systems.

Responsibilities

• Provide programming support for Clinical Data Management activities.
• Collaborate with Biostatisticians, Clinical Data Managers, and Regulatory teams to meet project timelines.
• Ensure completeness, accuracy and consistency of clinical data and data structures.
• Generate edit checks, listings and reports for regulatory submission and study reporting.
• Assist with data extraction, mapping, transformation, and loading of clinical data.

Skills

Clinical SAS

DM SAS

SAS Macros

SAS Listings

Education

Bachelor’s degree in Mathematics or Computer Science

Job description

Work location: Any IQVIA office Location In India

Work Mode: Hybrid

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

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.

Qualifications:

• 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.