16 Aug
|
Clario
|
Bengaluru
At Clario, a part of Thermo Fisher Scientific, our Cardiac Solutions team supports clinical trials worldwide through the delivery of high-quality statistical programming, analysis datasets, and regulatory submission packages. As a Statistical Programmer, you will play a key role in developing and validating CDISC-compliant datasets, supporting cardiac safety analyses, and ensuring regulatory-ready deliverables are produced with accuracy and efficiency. This role is ideal for a collaborative programming professional who enjoys working with clinical trial data and contributing to the development of life-changing therapies.
What We Offer
- Competitive pay and incentives
- Provident fund and medical insurance
- Engaging employee programs and local events
- Contemporary office spaces and remote work flexibility
What You'll Be Doing
- Produce, validate, and maintain submission-ready datasets to support cardiac safety clinical trials, including SDTM ECG (EG) and ADaM ADEG datasets.
- Create, test, and maintain SAS programs used to generate and validate CDISC-compliant datasets.
- Develop,
test, and implement data standards that support cardiac research and regulatory submissions.
- Perform double programming and validation activities to ensure the accuracy of statistical analysis datasets.
- Generate and interpret compliance checks for CDISC-formatted datasets, including SDTM and ADaM standards.
- Support research initiatives by providing programming expertise and analysis results to senior team members and department leadership.
- Create electronic submission packages, including Define.xml, reviewer guides, and supporting regulatory documentation in accordance with FDA submission requirements.
- Train team members on standard operating procedures, programming standards, and best practices.
- Identify and implement process improvements to enhance operational efficiency and data quality.
- Manage project timelines and client commitments to ensure on-time delivery of assigned de
📌 Statistical Programmer (Bengaluru)
🏢 Clario
📍 Bengaluru