Statistical Programmer II

🔥 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

• Assist in coordinating project start-up activities, creating global programs, tracking spreadsheets, and required documentation • Deliver high-value, high-quality statistical programming services for assigned projects • Produce derived datasets such as SDTM and ADaM, tables, figures, and data listings of any complexity • QC low- to medium-complexity derived datasets, tables, figures, and data listings • Assist with production and QC of derived dataset specifications, process-supporting documents, and submission documentation • Maintain and expand local and international regulatory knowledge within the clinical industry • Develop knowledge of SAS and processes/procedures within other Parexel functional areas • Provide training and mentorship to staff and project teams as appropriate • Maintain study-supporting documentation according to SOPs/Guidelines for traceability and regulatory compliance • Ensure compliance with SOPs/Guidelines, ICH-GCP, applicable regulations, and participate in audits and regulatory inspections • Participate in process and quality improvement initiatives • Apply regulatory requirements concerning CDISC, 21 CFR Part 11, and electronic submissions

🎯 Requirements

• Educated to degree level in a relevant discipline and/or equivalent work experience • Equivalent work experience may substitute for degree-level education • Excellent analytical skills • Proficiency in SAS • Knowledge and understanding of the programming and reporting process • Knowledge of SOPs/Guidelines, ICH-GCP, and applicable local and international regulations such as 21 CFR Part 11 • Ability to learn new systems and function in an evolving technical environment • Ability to manage competing priorities and flexibility to change • Attention to detail • Ability to successfully work as part of a global team • Effective time management to meet daily metrics or team objectives • Competent in written and oral English • Good communication skills