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Develop and validate CDISC-compliant datasets (SDTM and ADaM) to support cardiac safety clinical trials and regulatory submissions. Create SAS programs, maintain data standards, and produce electronic submission packages including Define.xml and reviewer guides.

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.

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