Senior Statistical Programmer, FSP

September 3

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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

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures • Perform programming validation to ensure quality of analysis datasets and programming outputs • Provide programming support for project teams including development of strategies, standards, specifications, and programmed analysis • Support electronic submission preparation and review • Review planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) and assess impact on programming activities • Interact with vendors regarding project standards, programming conventions, specifications and file transfers • Provide leadership to ensure quality and compliance with regulatory requirements and SOPs • Identify opportunities for increased efficiency and consistency and support improvement initiatives • Independently lead and perform programming assignments with minimal supervision

🎯 Requirements

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required • Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development • Demonstrated proficiency in analytical programming • In-depth understanding of clinical data structure (e.g., CDISC standards) and relational database • Skills in MS Office, XML, Pinnacle 21 • Experience handling and processing upstream data (multiple data forms, workflow, eDC, SDTM) • Experience providing outputs for downstream requirements (ADaM, Data Definition Table, e-submission) • Good understanding of regulatory, industry, and technology standards and requirements • Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs • Demonstrated ability to work in a team environment with clinical team members • Applicants must be authorized to work in Serbia; no visa sponsorship available

🏖️ Benefits

• Highly qualified and dynamic team • Multinational working environment • Smooth induction and training program • Competitive financial packages • Training and development • Healthy work/life balance • Fully flexible work arrangement (fully home based; Belgrade office optional)