Statistical Programmer

The Statistical Programmer will be responsible for developing, validating, and maintaining high-quality clinical trial programming deliverables while ensuring compliance with industry standards. Key responsibilities include:

• Developing, testing, validating, and maintaining SAS programs used to generate clinical trial datasets.


• Producing submission-ready datasets, including SDTM and ADaM datasets, to support clinical safety analyses.


• Creating and maintaining CDISC-compliant data standards and ensuring alignment with regulatory requirements.


• Performing double programming and validation activities to verify the accuracy and reliability of statistical analysis datasets.


• Generating and reviewing compliance checks for SDTM and ADaM formatted datasets.


• Supporting regulatory submission activities by preparing electronic submission packages, Define.xml files, reviewer guides, and related documentation.


• Collaborating with cross-functional teams to understand programming requirements and deliver project-level statistical outputs.


• Providing programming expertise and analytical support to senior team members and project stakeholders.


• Supporting onboarding, training, and knowledge sharing across programming teams.


• Contributing to the improvement of SOPs, work instructions, templates, quality standards, and operational processes.


• Managing project timelines, tracking deliverables, and ensuring assigned work is completed accurately and on schedule.

Requirements:

The ideal candidate has experience in statistical programming within clinical research, pharmaceutical, or related environments, with strong technical and analytical capabilities. Required qualifications and skills include:

• Bachelor’s degree in Statistics, Mathematics, Computer Science, Biostatistics, or a related quantitative discipline with relevant experience, or a Master’s degree in a related field.


• 3+ years of relevant experience with a Bachelor’s degree, or equivalent entry-level experience with a Master’s degree.


• Experience working in a pharmaceutical company, Contract Research Organization (CRO), or clinical research environment.


• Strong SAS programming skills, including experience developing and maintaining clinical trial datasets.


• Hands-on experience with CDISC standards, including SDTM and ADaM dataset creation and validation.


• Understanding of clinical trial protocols, Statistical Analysis Plans (SAPs), and pharmaceutical development processes.


• Experience supporting regulatory submissions and related documentation is preferred.


• Strong analytical, problem-solving, and data validation skills.


• Excellent written and verbal communication abilities.


• Strong organizational skills with the ability to manage multiple projects and priorities.


• Ability to work independently while collaborating effectively with global and cross-functional teams.


• Proficiency with Microsoft Office applications and Windows-based software environments.


• Adaptability and willingness to work in a fast-paced environment with changing priorities.

Benefits:

• Competitive salary and incentive opportunities.


• Provident fund and medical insurance coverage.


• Flexible work options, including remote work opportunities.


• Opportunity to contribute to global clinical research and healthcare innovation.


• Exposure to advanced clinical data standards and regulatory submission processes.


• Employee engagement programs and professional development opportunities.


• Collaborative environment with opportunities for learning and knowledge sharing.