Bengaluru, India | Full time | Home-based | R1557080

The Principal Stat Programmer plays a critical role in ensuring the accuracy and integrity of statistical programming across various clinical projects. This position demands proficiency in SAS programming and familiarity with CDISC standards, particularly ADaM and SDTM models. The role re

quires experience in Safety and/or Efficacy analysis programming, including creation of efficacy datasets and efficacy outputs, ADaM specifications writing, and regulatory submission documentation. Key responsibilities include developing and validating complex data sets and outputs, collab

orating with cross-functional teams to optimize processes, and providing technical guidance on statistical methodologies and programming best practices. The role also involves mentoring junior programmers and contributing to the continuous improvement of programming workflows and standards, supporting the overall quality deliverables of the statistical programming department.

Essential Functions:




- Develops and validates complex datasets and outputs using SAS programming, ensuring compliance with CDISC standards such as ADaM and SDTM models.
- Performs Safety and/or Efficacy analysis programming, including creation of efficacy datasets and efficacy outputs (Tables, Listings, and Figures).
- Authors and reviews ADaM specifications for Safety and/or Efficacy analyses in compliance with CDISC standards.
- Creates and maintains regulatory submission documentation including Analysis Data Reviewer’s Guide (ADRG) and Define.xml.
- Utilizes Pinnacle 21 (P21) to validate datasets and ensure submission readiness and compliance with regulatory requirements.
- Collaborates with cross-functional teams to optimize statistical programming processes and enhance overall efficiency and accuracy.
- Provides technical guidance and expertise on statistical methodologies to support clinical trial projects and departments.
- Mentors and guides junior programmers,

📌 Prin Stat Programmer (Bengaluru)
🏢 Iqvia
📍 Bengaluru