HybridOperations, Data ManagementFull time
Bengaluru, Karnataka, India
OVERVIEW
Description
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team Lead SDTM programmer. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
The Lead SDTM Programmer is responsible for providing SDTM Programming input for Data Management activities dedicated to one Sponsor. They are responsible for ensuring all clinical programming aspects per client SOPs are delivered to high quality.
Main Responsibilities
Responsible for building SDTM data models using SAS & other ETL tools.
Deep understanding of SDTM and its implementation in Oncology and Cardiovascular TA’s
Able to set up SAS QC environment & programs for data set validation.
Deep understanding of IG and requirements
Knowledge of Pinnacle 21. Should be able to use Pinnacle 21 Enterprise version for a given study for data set validations.
Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance.
Requirements
At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.
- Experience: Seven or more years of experience in SDTM/ SAS Programming
- Skills: Deep understanding of SDTM and its implementation in Oncology and Cardiovascular TA’s
- Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance.
Technical inclination to learn other ETL tools to develop Data sets.
- Education: Bachelor’s degree qualification
- Languages: Fluent in English (written and spoken), Effective verbal and written communication skills.
Benefits
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here’s what makes us unique—
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model — offering full-service, functional service provider, and consulting — enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
Excelling with Care
At Excelya, Care lies at the heart of what we do. We provide equal opportunities for all and foster a diverse, equitable, and inclusive workplace where humility and boldness work hand in hand. Everyone has a space to feel valued, thrive, and collaborate with purpose.
Your challenges become our shared mission. Together, we transform bold ideas into reality—the Excelya way.
Apply today, become an Excelyate!
