Senior Statistical Programmer – FSP

3 days ago

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Parexel

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Healthcare Insurance • Biotechnology • Pharmaceuticals

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.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Ability to fill Statistical Programming Lead role on projects • Ensure that timelines are adhered to • Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget • Monitor project resourcing, project budgets, and identify changes in scope • Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation • Interact with sponsors and internal stakeholders with regard to statistical programming issues • Deliver best value and high quality service • Check own work in an ongoing way to ensure first-time quality • Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings • Produce/QC dataset specifications and other process supporting documents and submission documentation • Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements

🎯 Requirements

• Excellent analytical skills • Proficiency in SAS • Extensive knowledge and understanding of the programming and reporting process • Knowledge of SOPs/Guidelines, ICH-GCP, and any other 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 • Ability to successfully lead a global team • Work effectively in a quality-focused environment • Effective time management in order to meet daily metrics or team objectives • Show commitment to and perform consistently high quality work • Business/operational skills that include customer focus, commitment to quality management, and problem solving • Good presentation skills • Good business awareness/business development skills (including financial awareness)

🏖️ Benefits

• Maintain and expand local and international regulatory knowledge within the clinical industry • Provide relevant training and mentorship to staff and project teams • Proactively participate in and/or lead process/quality improvement initiatives