Statistical Programmer - jobgether

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: