Statistical Programmer

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.