Senior Statistical Programmer, SAS Programmer

🔥 0 minutes ago

🌐 United Kingdom, Hungary, +2 more countries – Remote

🇬🇧 United Kingdom – Remote 🇭🇺 Hungary – Remote 🇵🇱 Poland – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

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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

• Provide technical expertise for the conduct of clinical trials • Act as an internal subject matter expert and provide technical support and expert advice • Support programming activities related to analysis and reporting of clinical study data • Fill the Statistical Programming Lead role on projects when required • Liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas • Monitor quality, timelines, resource allocation, productivity, and budgets • Negotiate and manage statistical programming timelines • Coordinate and lead statistical programming teams to complete studies within timelines and budget • Monitor project resourcing, budgets, and scope changes • Coordinate project start-up activities and required documentation • Review statistical analysis plans, mock-shells, and database set-up specifications • Resolve problems encountered by project teams • Produce and QC derived datasets, tables, figures, and data listings using efficient programming techniques • Produce and QC dataset specifications, process documents, and submission documentation • Perform QC in accordance with quality standards, SOPs/Guidelines, ICH-GCP, and regulatory requirements • Provide training and mentorship • Maintain study documentation for traceability and regulatory compliance • Participate in audits and regulatory inspections • Lead or participate in process and quality improvement initiatives • Provide consultancy to internal and external sponsors • Represent Parexel at sponsor marketing and technical meetings • Apply regulatory requirements concerning CDISC, 21 CFR Part 11, and electronic submissions

🎯 Requirements

• University degree • Strong written and verbal English communication skills • Proficiency in SAS • Excellent analytical skills • Ability to successfully lead a global team • Extensive 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 • Strong project management skills • Strong organizational skills, ability to manage competing priorities, and flexibility to change • Attention to detail • Effective time management to meet daily metrics or team objectives • Business/operational skills including customer focus, commitment to quality management, and problem solving • Good presentation skills • Good business awareness/business development skills, including financial awareness

🏖️ Benefits

• Professional growth and development opportunities • Work-life balance • Flexible working hours