Statistical Programmer

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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1