Lead Clinical Data Science Programmer

ICON plc

2 - 5 years

7 - 8 Lacs

chennai bengaluru thiruvananthapuram

Posted:3 hours ago| Platform:

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Skills Required

clinical operations c# fda python inform sas medidata rave edc clinical programming drug development ich sql clinical data r gcp crf oracle clinical asp.net clinical trials data review base sas clinical study report communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

Serve as the primary point of contact for system programming during study setup, collaborating with cross-functional teams.
Translate clinical study reporting needs into specifications and develop custom data review solutions using tools like JReview, Spotfire, and SAS.
Build and maintain global standard reports integrating CRF, biomarker, and eCOA data.
Design and implement advanced SQL queries, stored procedures, and visual analytics dashboards.
Contribute to SOPs, working procedures, and internal documentation to support functional excellence.
Support metadata management and MDR system updates.
Deliver role-based training and generate compliance and metrics reports to support clinical operations.
Identify and mitigate project risks, ensuring high-quality deliverables and timely communication with stakeholders.

Profile Expectations

Strong understanding of the end-to-end drug development process and FDA/ICH/GCP guidelines.
Proven experience in clinical data reporting and analytics, with proficiency in SQL; knowledge of SAS, R, Python, and visualization tools is a plus.
Excellent communication and organizational skills in a matrixed, cross-functional environment.
Experience with EDC systems (Rave) and familiarity with computerized systems regulations in clinical trials.
Ability to work independently, manage multiple priorities, and deliver high-quality outputs under tight timelines.
Strong analytical mindset with a proactive approach to problem-solving and innovation.
Experience in stakeholder engagement, requirement gathering, and translating business needs into technical solutions.

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