Senior Report Programmer

Job Title: Senior Report Programmer

Department: Clinical Data Reporting / Biometrics / Data Analytics

Location: Pan India, Remote

Experience Level: 6+ years

Position Summary

The Senior Report Programmer is responsible for developing, validating, deploying, and maintaining high-quality data review and visualization reports used by clinical study teams for data monitoring, data cleaning, and decision-making.

This role requires strong technical programming skills in SAS and SQL, and hands-on experience with data visualization platforms such as JReview, Spotfire, Power BI, Tableau, or Qlik. The candidate will collaborate closely with Data Management, Biostatistics, and Clinical Operations to translate business requirements into technical specifications and deliver automated, standardized, and compliant data review solutions.

Key Responsibilities

1 Report Development & Automation

• Design, develop, validate, and maintain global standard and study-specific clinical data review reports using SAS, SQL, and visualization platforms (JReview, Spotfire, Power BI, etc.).
• Create patient profiles, safety review dashboards, data listings, and summary reports to support clinical teams.
• Develop reusable macros, templates, and scripts to ensure consistency and efficiency across studies.
• Automate report generation and distribution processes wherever feasible.

2 Data Extraction & Integration

• Extract, transform, and integrate data from multiple clinical data sources including Rave EDC, eCOA, biomarker, and external lab data.
• Write complex SQL queries and SAS programs to combine and structure data for reporting needs.
• Ensure data accuracy, completeness, and traceability throughout the reporting process.

3 Quality Control & Validation

• Perform rigorous QC and peer reviews of reports and programming outputs.
• Maintain compliance with regulatory requirements (GCP, CDISC, 21 CFR Part 11).
• Ensure alignment with internal data standards, naming conventions, and reporting templates.

4£ Requirement Analysis & Documentation

• Collaborate with Clinical Data Management and Biostatistics to understand study-specific data review needs.
• Translate reporting requirements into technical specifications, data flow diagrams, and validation plans.
• Document all report logic, assumptions, and design decisions in accordance with SOPs and audit requirements.

5£ Deployment & Maintenance

• Deploy and manage reports on global reporting platforms (e.g., JReview, Spotfire server).
• Maintain version control, access permissions, and refresh schedules for live dashboards.
• Provide post-deployment support, enhancements, and troubleshooting as required.

6£ Cross-Functional Collaboration

• Partner with Data Managers, Biostatisticians, Programmers, and Clinical Operations teams to deliver end-to-end reporting solutions.
• Mentor junior report programmers and contribute to the development of best practices, reporting standards, and automation initiatives.
• Participate in cross-functional working groups focused on data quality improvement and reporting efficiency.

Required Qualifications

• Education: Bachelors or Masters degree in Computer Science, Life Sciences, Statistics, or related field.
• Experience: Minimum 6+ years in clinical reporting, programming, or analytics within the pharma, CRO, or biotech industry.

• Technical Skills:

• Advanced programming expertise in SAS and SQL.

• Experience with data visualization/reporting tools: JReview, Spotfire, Power BI, Tableau, or Qlik.
• Familiarity with Rave EDC and other clinical data systems.

• Understanding of CDISC standards (SDTM/ADaM) and clinical data structures.

• Soft Skills:

• Strong analytical thinking and problem-solving skills.

• Excellent communication and documentation abilities.
• Ability to manage multiple studies and priorities independently.

Preferred Qualifications

• Experience in global clinical reporting standardization initiatives.
• Exposure to Python or R for data analytics or automation.
• Familiarity with data warehousing concepts or ETL processes.
• Experience working in a regulated environment (GxP / 21 CFR Part 11).
• Knowledge of drug development lifecycle and clinical trial processes.

Key Competencies

• Attention to detail and commitment to data accuracy.
• Proactive and solution-oriented mindset.
• Collaborative team player with leadership potential.
• Strong time management and accountability for deliverables.

Performance Indicators (KPIs)

• On-time delivery of validated reports.
• Accuracy and quality of data outputs.
• Adherence to coding standards and SOPs.
• Stakeholder satisfaction with reporting solutions.
• Contribution to process automation and improvement.