Principal Programmer – RWD, SDTM

This is a fully remote position, open to applicants in India.

📋 Description

• Lead and execute SDTM mapping and conversion tasks for Real-World Data (RWD) to CDISC standards.

• Analyze intricate RWD datasets and align them with the relevant SDTM domains, variables, and controlled terminology.

• Create and evaluate ECRT packages, including aCRF, Define.xml, and CSDRG.

• Serve as a Subject Matter Expert (SME) in SDTM and CDISC standards.

• Operate autonomously on sophisticated programming projects with minimal oversight.

• Collaborate across functions and communicate effectively with stakeholders.

• Document essential decisions, mappings, and discussions through PowerPoint presentations, meeting notes, and other means.

• Ensure strict adherence to the principles outlined in the Phastar checklist.

• Archive study documentation in accordance with instructions provided in relevant SOPs.

• Function as a Lead Programmer, guaranteeing quality and timely project delivery.

• Coordinate with the Study Statistician and Project Manager regarding resource allocation and deliverables.

• Evaluate and oversee study-level resources.

• Serve as the primary contact for programming-related issues within the team, proactively ensuring cohesive operations.

• Encourage stakeholders to adhere to best practices throughout the trial process.

• Contribute to the development of internal training programs.

⛳️ Requirements

• Over 5 years of experience in CDISC and clinical trials.

• Strong proficiency in SDTM, including controlled terminology.

• Robust programming skills, particularly in SAS, along with substantial clinical trial experience.

• Familiarity with ECRT packages, such as aCRF, Define.xml, and CSDRG.

• A Bachelor’s degree or higher in Computer Science, Mathematics, or a related scientific discipline.

• Ability to think analytically and creatively when dealing with complex data interpretations.

• Outstanding communication and documentation skills.

• Experience with Real-World Data (RWD).

• Exposure to biomarker data.

🏝️ Benefits

• Flexible working arrangements.

• Part-time hours available.

• Structured training and development programs.

• Opportunities for continuous learning.

• Competitive salary and comprehensive benefits package.