Statistical Programmer

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Clario

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1973

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

💰 Private Equity Round on 2019-10

Healthcare Insurance • Biotechnology • Artificial Intelligence

Clario is a company specializing in accelerating clinical trials from initiation to implementation through advanced technologies and services. Since 2018, Clario has revolutionized endpoint analyses in clinical trials by integrating over 30 artificial intelligence-enabled solutions across more than 600 active trials, enhancing data quality and patient privacy while expediting data collection processes. Clario provides a comprehensive clinical trial management platform, offering solutions such as eCOA, cardiac safety, medical imaging, precision motion, and respiratory services in various therapeutic areas including oncology, cardiology, and neurology. Known for its global reach, Clario supports clinical trials in over 100 countries with a strong focus on decentralized and hybrid trial models. The company's commitment to patient safety and innovation is reflected in their over 26,000 trials and involvement in numerous new drug approvals.

📋 Description

• Produce, validate, and maintain submission-ready datasets to support cardiac safety clinical trials, including SDTM ECG (EG) and ADaM ADEG datasets. • Create, test, and maintain SAS programs used to generate and validate CDISC-compliant datasets. • Develop, test, and implement data standards that support cardiac research and regulatory submissions. • Perform double programming and validation activities to ensure the accuracy of statistical analysis datasets. • Generate and interpret compliance checks for CDISC-formatted datasets, including SDTM and ADaM standards. • Support research initiatives by providing programming expertise and analysis results to senior team members and department leadership. • Create electronic submission packages, including Define.xml, reviewer guides, and supporting regulatory documentation in accordance with FDA submission requirements. • Train team members on standard operating procedures, programming standards, and best practices. • Identify and implement process improvements to enhance operational efficiency and data quality. • Manage project timelines and client commitments to ensure on-time delivery of assigned deliverables. • Maintain accurate project status, milestones, and deliverable tracking information. • Contribute to the development and maintenance of SOPs, Standard Work Instructions (SWIs), checklists, playbooks, templates, and quality standards. • Collaborate with cross-functional teams to define programming requirements and support project-level statistical deliverables. • Support onboarding and training of new team members and promote knowledge sharing across the organization.

🎯 Requirements

• Bachelor's degree in Statistics, Mathematics, Computer Science, Biostatistics, or a related quantitative discipline with 3+ years of relevant experience; or Master's degree with 0–1 years of relevant experience. • Experience working within a pharmaceutical company, Contract Research Organization (CRO), or clinical research environment. • Strong SAS programming experience, including the development and maintenance of clinical trial datasets. • Experience creating, validating, and maintaining CDISC-compliant datasets, including SDTM and ADaM standards. • Understanding of clinical trial protocols, Statistical Analysis Plans (SAPs), and the pharmaceutical drug development process. • Experience supporting regulatory submission activities and deliverables preferred. • Strong analytical, problem-solving, and data validation skills. • Excellent verbal and written communication skills. • Strong organizational skills with the ability to manage multiple projects and priorities simultaneously. • Proficiency with Microsoft Office applications and Windows-based software environments. • Ability to work independently and collaboratively within cross-functional teams. • Adaptability and flexibility in a fast-paced environment with changing priorities.

🏖️ Benefits

• Competitive pay and incentives • Provident fund and medical insurance • Engaging employee programs and local events • Modern office spaces and remote work flexibility