Statistical Programmer II – SDTM

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥 Software Engineer

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Review and provide feedback on Protocol and SAP related to SDTM mappings • Develop SDTM trial design domains • Program complex SDTM datasets • Debug simple to moderate macros • Support SDTM Lead • Assist in coordination of project start-up activities • Prepare submission packages • Serve as a key statistical programming contact on assigned projects • Collaborate with sponsors, Data Operations Leads, and cross-functional teams • Develop and review SDTM mappings, trial design domains, and complex SDTM datasets • Apply efficient programming techniques • Support process improvements through macro and application development • Contribute to regulatory submissions and critical study decisions

🎯 Requirements

• Bachelor's degree or Master's degree in Life Sciences, Computer Science, Pharmacy, or another relevant discipline, or equivalent experience • 3+ years of experience in SDTM statistical programming • Proficiency in SAS and knowledge of programming and reporting processes • Understanding of regulatory requirements and industry technical standards related to clinical trial data • Experience developing SDTM trial design domains and complex SDTM datasets • Excellent written and verbal communication skills, including competency in written English • Strong organizational, teamwork, and project management skills • Ability to adapt to changing priorities while supporting complex project deliverables • Understanding of efficacy endpoints and efficacy concepts (e.g., RECIST application, IMWG) • Strong skills in SAS programming, SDTM dataset development, and problem solving • Experience working in clinical research or another regulated environment • Simple to moderate macro debugging • Solid SAS basic skills

🏖️ Benefits

• Continuous learning opportunities • Career growth opportunities • Diverse teams • Remote work capacity