About this role
At Clario, a part of Thermo Fisher Scientific, our Cardiac Solutions team supports clinical trials worldwide through the delivery of high-quality statistical programming, analysis datasets, and regulatory submission packages. As a Statistical Programmer, you will play a key role in developing and validating CDISC-compliant datasets, supporting cardiac safety analyses, and ensuring regulatory-ready deliverables are produced with accuracy and efficiency. This role is ideal for a collaborative programming professional who enjoys working with clinical trial data and contributing to the development of life-changing therapies.
What We Offer
• Competitive pay and incentives
• Provident fund and medical insurance
• Engaging employee programs and local events
• Modern office spaces and remote work flexibility
What You'll Be Doing
• 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.
What We Look For
• 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.
At Clario, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.