Principal Statistical Programmer

Johnson & Johnson; Stevenage; On-site; GBP 80,000 - 100,000; Full time

Job summary

A global healthcare company based in the UK is seeking a candidate for a clinical data management position. This role involves overseeing clinical data management trial activities, creating report solutions, and improving programming deliverables. The ideal candidate should have advanced analytics, data modeling, and SAS programming skills. You will ensure compliance with clinical data standards and contribute to process improvements. This position offers an opportunity to work in a dynamic environment focused on quality and compliance.

Responsibilities

• Oversight of clinical data management trial activities.
• Creating and executing edit check programs and reports.
• Comprehensive review of project requirements and documentation.
• Ensuring standards and technologies are current.
• Developing and implementing process and system improvements.

Skills

Advanced Analytics

Analytical Reasoning

Biological Sciences

Biostatistics

Clinical Trials

Data Modeling

Data Privacy Standards

Data Quality

Data Savvy

Detail‑Oriented

Good Clinical Practice (GCP)

Report Writing

Research Ethics

Researching

Statistical Analysis Systems (SAS) Programming

Statistics

Technologically Savvy

Job description

Responsibilities

The position is responsible for oversight of one or more clinical data management trial activities of moderate to high complexity/criticality, including data model specifications, data stream integrations, and transformation of source to internal data models and/or CDISC submission‑ready SDTM tabulation packages (aCRF, define.XML, cSDRG, etc.). Creates and executes edit check programs, listings, and report solutions to aid in monitoring safety, risk, compliance, and ensures quality data review.

Performs reporting solutions role, creating study‑specific reports that translate clinical study team needs into specifications, aggregating clinical data sources into custom data and reporting to monitor safety, risk and compliance.

Accountable for one or more clinical programming trial activities of moderate to high complexity, scope and/or criticality; performs comprehensive review of project requirements and documentation, identifies gaps, proposes solutions, and applies expertise to improve efficiency and overall quality of programming deliverables.

Ensures latest standards are being utilized and current technologies deployed; creates and/or reviews specifications for mapping internal data models for fit‑for‑purpose reporting and/or submission‑ready CDISC SDTM. Designs mapping algorithms for non‑standard conversions.

Program or oversee quality review checks and study‑specific reports for use by team members and data consumers; may aggregate clinical data sources into custom data models for fit‑for‑purpose consumption and study‑specific report solutions, performing appropriate quality control and verification in support of assigned reporting activities.

Supports and/or leads in developing and implementing process, system and tool improvement initiatives within compliance with departmental processes and procedures.

Required Skills

• Advanced Analytics
• Analytical Reasoning
• Biological Sciences
• Biostatistics
• Clinical Trials
• Data Modeling
• Data Privacy Standards
• Data Quality
• Data Savvy
• Detail‑Oriented
• Good Clinical Practice (GCP)
• Report Writing
• Research Ethics
• Researching
• Statistical Analysis Systems (SAS) Programming
• Statistics
• Technologically Savvy

Preferred Skills

• Advanced Analytics
• Analytical Reasoning
• Biological Sciences
• Biostatistics
• Clinical Trials
• Data Modeling
• Data Privacy Standards
• Data Quality
• Data Savvy
• Detail‑Oriented
• Good Clinical Practice (GCP)
• Report Writing
• Research Ethics
• Researching
• Statistical Analysis Systems (SAS) Programming
• Statistics
• Technologically Savvy