Job Description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Statistical Programmer based in India.

This role offers the opportunity to contribute to global clinical research initiatives by transforming complex trial data into reliable, regulatory-ready outputs.
The Statistical Programmer will support the creation and validation of clinical datasets that help advance evidence-based healthcare solutions.
You will work with industry-standard programming practices, clinical data standards, and regulatory requirements to ensure high-quality deliverables.
The position combines technical expertise, analytical thinking, and collaboration with cross-functional teams in a dynamic research environment.
You will play an important role in improving data quality, supporting submissions, and enabling accurate clinical safety analyses.
This opportunity is ideal for a detail-oriented programming professional passionate about clinical research, data standards, and healthcare innovation.

Accountabilities:

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.