Experienced Statistical Programmer

About Johnson & Johnson

Johnson & Johnson is committed to health innovation, aiming to prevent, treat, and cure complex diseases with smarter, less invasive, and personalized treatments. Leveraging expertise in Innovative Medicine and MedTech, the company seeks to impact global health through breakthroughs.

Johnson & Johnson values a diverse and inclusive workplace that respects the dignity and individuality of each employee.

Role Summary

The Experienced Statistical Programmer collaborates as an individual contributor within a programming team, supporting data analysis and reporting for clinical trials with low to medium complexity or criticality. The role requires development and verification of statistical programs and delivering high-quality outputs aligned with departmental standards and regulatory requirements.

Key Responsibilities

• Lead or complete programming activities related to clinical trials, ensuring timely and quality deliverables for trials of low to medium complexity or criticality.
• Design and develop programming solutions supporting clinical research data analysis and reporting.
• Perform verification and quality checks of programming outputs and assist in reviewing project documentation and requirements.
• Support regulatory submission efforts, including creating, verifying, and delivering CDISC-compliant and other required data packages and guides.
• Adhere to departmental standards, stay current with industry best practices, and contribute to process innovation and improvement initiatives.
• Work collaboratively with internal teams and cross-functional partners, including data management, monitoring, statistics, regulatory, and project management groups.
• Maintain compliance with company training, reporting, and other operational policies.
• Review internal Data Review Models (DRM) and verify fit-for-purpose reporting mappings.
• Assist with data cleaning via programming edit checks and develop data visualizations and listings to support data management and medical monitoring functions.

Collaborations

This role reports to a people manager within the Delivery Unit and coordinates with Portfolio and Study Leads. Key internal partnerships include teams from Data Management, Central Monitoring, Programming, Clinical Data Standards, Medical Writing, and Regulatory. External interactions involve partners, CROs, vendors, and industry working groups.

Qualifications and Experience

• Bachelor’s degree or higher in computer science, data science, mathematics, public health, or related scientific fields with equivalent theoretical or technical proficiency.
• Approximately 2 or more years of relevant programming experience, preferably in pharmaceutical, CRO, or biotech sectors.
• Familiarity with clinical research concepts and regulatory guidelines like ICH-GCP.
• Ability to work effectively in team environments.
• Strong oral and written communication skills.
• Understanding of data structures and proficiency in programming languages used for data manipulation, statistical analysis, and reporting, including SAS (preferred), R, and Python.
• Basic knowledge of programming processes, methods, and clinical data standards.

Additional Information

• Exposure to statistical analysis systems and clinical trial data modeling preferred.
• Detail orientation and technological savvy valued.
• Knowledge of data privacy standards, good clinical practice, and research ethics emphasized.