Phastar

Principal Programmer – RWD, SDTM

Phastar

full-time

Posted on:

Location Type: Remote

Location: India

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Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SDTMCDISC standardsSASECRT packagesaCRFDefine.xmlCSDRGprogrammingdata mappingdata interpretation
Soft Skills
analytical thinkingcreative thinkingcommunicationdocumentationcollaborationleadershippersuasionindependenceproblem-solvingstakeholder engagement