Principal Programmer – RWD, SDTM

🕒 April 14

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

👻 Ghost score 45%

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Phastar

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2007

🏥 Healthcare

💼 Consulting

💊 Pharmaceuticals

Healthcare • Consulting • Pharmaceuticals

Phastar is a global biometrics contract research organization (CRO) that provides end-to-end clinical data solutions, including biostatistics, statistical programming, data management, data science, and data visualization to support clinical trials and regulatory submissions. The company offers flexible, scalable delivery models (project-based and functional service partnerships), proprietary frameworks and analytics tools to prepare high-quality, submission-ready data, and emphasizes a right-first-time approach and regulatory-first quality standards to accelerate drug development.

📋 Description

• Lead and deliver SDTM mapping and conversion activities for RWD to CDISC standards • Interpret complex RWD datasets and map them to appropriate SDTM domains, variables, and controlled terminology • Develop and review ECRT packages including aCRF, Define.xml, and CSDRG • Act as a Subject Matter Expert (SME) in SDTM and CDISC standards • Work independently on complex programming tasks with minimal supervision • Collaborate cross-functionally and communicate effectively with stakeholders • Document key decisions, mappings, and discussions (PowerPoint, meeting notes, etc.) • Ensure the principles in the Phastar checklist are followed rigorously • Archive study documentation following instructions in supplied SOPs • Act as a Lead Programmer, ensuring quality and timely delivery • Liaise with the Study Statistician and Project Manager regarding resourcing and deliverables • Assess and monitor study level resources • Point of contact for programming issues for the team, proactively ensuring everything is working cohesively • Persuade stakeholders to follow best practice within a trial • Assist in development of internal training courses

🎯 Requirements

• 5 +years of CDISC and clinical trials experience • Strong expertise in SDTM (including controlled terminology) • Solid programming skills with strong SAS and clinical trial experience • Experience in ECRT packages (aCRF, Define.xml, CSDRG) • Educated to BSc or above within Computer Science, Mathematics or a Science related discipline • Ability to think analytically and creatively when interpreting complex data • Excellent communication and documentation skills • Experience with Real-World Data (RWD) • Exposure to biomarker data

🏖️ Benefits

• Flexible working • Part-time hours • Structured training and development plans • Continuous learning opportunities • Competitive salary and benefits package