Job Description

Job title : Principal Statistical Programmer
Reports to : VP Operations

Job Purpose :
To lead the programming, validation, and delivery of high-quality statistical outputs for clinical trials by applying advanced SAS programming and CDISC standards, ensuring data integrity, regulatory compliance, and timely support of statistical analyses, clinical study reports, and regulatory submissions through close collaboration with biostatistics, data management, and clinical teams.

Duties and responsibilities :
Programming & Data Management :
- Develop and maintain SAS programs for clinical trial data processing, analysis, and reporting.
- Map clinical trial data to CDISC standards (SDTM and ADaM) ensuring compliance with regulatory requirements.
- Create and maintain analysis datasets following CDISC implementation guidelines.
- Perform data validation and quality control checks to ensure data integrity.
- Expertise as Clinical SAS programmer: SAS programming language and software within the context of clinical research and healthcare,



particularly in the pharmaceutical and biotechnology industries.
- Managing, analyzing, and reporting clinical trial data, ensuring accuracy, efficiency, and regulatory compliance.
- Data Management: SAS excels at handling large and complex datasets from various sources, including EDC systems and laboratory databases.
- Data Cleaning and Transformation: to facilitate identifying and resolving data discrepancies, transforming variables, and preparing data for analysis.
- Statistical Analysis: wide range of statistical procedures for analyzing clinical trial data, including descriptive statistics, regression analysis, survival analysis, and analysis of variance (ANOVA).
- Safety Reporting: generates safety reports and listings to monitor adverse events and safety data during the trial.
- SDTM (Standard Data Tabulation Model) and ADaM (Analysis Data Model) Implementation supports the conversion of clinical trial data into stan

📌 Principal Statistical Programmer (India)
🏢 Ocugen India
📍 India