Senior Statistical Programmer, Georgia, Poland, Serbia, Hungary

🔥 0 minutes ago

🌐 Georgia, Poland, +2 more countries – Remote

🇬🇪 Georgia – Remote 🇵🇱 Poland – Remote 🇷🇸 Serbia – Remote 🇭🇺 Hungary – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

👻 Ghost score 10%

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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 in specific areas, providing technical support and expert advice. • Work independently on programming activities related to analysis and reporting of clinical study data. • 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 programming strategies, standards, specifications, and programmed analysis. • Support electronic submission preparation and review. • Review statistical analysis plans, data presentation plans, and data review plans for alignment, clarity, completeness, and programming impact. • Interact with vendors regarding project standards, programming conventions, specifications, and file transfers. • Lead quality assurance for deliverables through standards, regulatory requirements, guidance, SOPs, and work practices. • Identify opportunities for increased efficiency and consistency within the team and vendor interactions. • Independently lead and/or perform programming assignments with minimal supervision. • Support improvement initiatives.

🎯 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. • Proficiency in SAS is required. • Experience with R would be a strong asset. • In-depth understanding of clinical data structure, including CDISC standards, and relational databases. • Demonstrated ability in handling and processing upstream data, including multiple data forms, workflow, eDC, and SDTM. • Demonstrated ability in providing outputs to meet downstream requirements, including ADaM, Data Definition Table, and e-submission. • Demonstrated skills in using software tools and applications, including MS Office, XML, and Pinnacle 21. • Good understanding of regulatory, industry, and technology standards and requirements. • Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. • Applicants must be authorized to work in Georgia, Poland, Serbia, or Hungary. • Unable to sponsor or take over sponsorship of an employment Visa.

🏖️ Benefits

• Competitive financial packages • Training and development • Smooth induction and training program • Fully flexible work arrangement • Fully home based work option • Healthy work/life balance • Employee welfare support