Experienced Statistical Programmer

About Johnson & Johnson Innovative Medicine

Johnson & Johnson Innovative Medicine dedicates itself to researching, developing, and commercializing cutting-edge pharmaceutical therapies. Their portfolio addresses critical therapeutic areas including oncology, immunology, neuroscience, cardiovascular, and metabolic disorders. The company emphasizes innovation and patient-focused solutions leveraging advanced science to transform healthcare globally.

Role Overview

The Experienced Statistical Programmer operates as a key individual contributor within the Integrated Data Analytics and Reporting (IDAR) team. This role supports clinical trial data analysis and reporting in line with internal processes. The candidate will predominantly manage programming tasks for trials of low to medium complexity, ensuring accuracy, compliance, and timeliness, while also potentially engaging in initiatives aimed at innovation and process refinement within the department.

Key Responsibilities

• Execute and sometimes lead programming activities supporting clinical trials of low to moderate complexity with high-quality outputs.
• Design and develop programs that facilitate clinical research data analyses and reporting.
• Conduct thorough verification of programming work and statistical reporting outputs.
• Review and contribute to documentation including project requirements.
• Support regulatory submission activities by preparing and validating CDISC compliant or specialized data packages and reviewer guides.
• Adhere strictly to departmental standards, latest data standards, and advanced technology usage.
• Work collaboratively with cross-functional teams and contribute to process improvement initiatives.
• Maintain compliance with company and department training and operational requirements.
• Review mapping of internal Data Review Model specifications and verify their suitability for reporting purposes.
• Develop data cleaning programs, edit checks, data review reports, visualizations, and listings for various stakeholders such as data management and medical monitoring.

Collaboration and Reporting

This position reports to a people manager within the delivery unit and liaises closely with portfolio and study leads. Key collaborations extend to data management, central monitoring, clinical data standards, regulatory medical writing, and partner relations. Cross-functional interaction includes statistics, clinical teams, medical safety, project management, regulatory affairs, and strategic partnerships.

Educational and Professional Credentials

• Bachelor’s degree or higher in computer science, data science, data engineering, mathematics, public health, or related scientific disciplines, or equivalent technical expertise.
• Minimum of approximately two years of relevant experience in clinical programming, ideally within pharmaceutical, CRO, or biotechnology environments.
• Working knowledge of clinical R&D concepts and familiarity with regulatory frameworks like ICH-GCP.
• Effective communication skills, both written and verbal, and capability to work in team settings.

Technical Expertise

• Proficient understanding of data structures and programming languages related to data processing and statistical analysis, including SAS (preferred for clinical programming), R, and Python.
• Basic comprehension of programming methodologies, processes, and regulatory compliance.

Additional Notes

The hiring organization embraces diversity and provides an inclusive workplace that values individual merit. Applicants are encouraged to verify current role details directly with the company before applying.