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Marco Ameglio

@marcoameglio

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Senior statistical programmer and data management lead in pharmaceutical clinical trials.

Italy

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What I'm looking for

I seek senior roles in clinical data or statistical programming where I can lead EHR-to-EDC integrations, improve processes, and drive regulatory-ready deliverables in collaborative, innovation-driven teams.

I am a Chemical Engineer turned clinical data and statistical programming professional with extensive experience in pharmaceutical development, process design, and digital health integration. Over nearly two decades at Janssen (Johnson & Johnson) and Actelion, I led EHR-to-EDC acquisition workflows, designed cross-functional operating models, and delivered tables, listings and figures for oncology and cardiopulmonary trials.

I have driven process improvements, stakeholder alignment, and digital health platform integrations, and served as a subject-matter expert on data initiatives (QuickBase, Tableau). My hands-on programming background includes SAS, SQL, ADaM standards and documentation for regulatory submissions and inspections.

I bring strong analytical, data governance and team coordination skills, with a proactive, international-team mindset and a track record of enabling efficient, compliant clinical data flows and high-quality statistical outputs.

Experience

Work history, roles, and key accomplishments

Senior Statistical Programmer

Johnson & Johnson Innovative Medicine - Janssen-Cilag S.p.A.

Jan 2018 - Jan 2025 (7 years)

Designed and implemented tables, listings, and figures for cardiopulmonary trials supporting final study reports, regulatory submissions, interim analyses and publications; developed patient profiles and report layouts.

SAS Statistical Programming Trial Reporting Regulatory Submissions Data Visualization Documentation

Data Management Process Lead

Johnson & Johnson Innovative Medicine - Janssen-Cilag S.p.A.

Jan 2018 - Jan 2025 (7 years)

Led process management for acquisition of Electronic Health Records into EDC for oncology clinical trials, designing workflows and cross-functional operating models to improve efficiency and ensure alignment with Global Development strategy.

EHR Integration EDC Process Design Stakeholder Management Change Management Clinical Data Management Digital Health Workflow Optimization

Digital Health Integration Specialist

Johnson & Johnson Innovative Medicine - Janssen-Cilag S.p.A.

Jan 2020 - Jan 2021 (1 year)

Managed integration activities for Digital Health platforms, inventoried Global Development integration platforms and defined a Capability Reference Model to standardize platform capabilities.

Digital Health Inventory Global Development Requirements Definition

Statistical Programmer

Actelion

Jan 2007 - Jan 2018 (11 years)

Programmed statistical reports, summaries and listings for clinical trials (psoriasis, MS, PAH), produced documentation for regulatory submission and contributed to ADaM standards and inspection materials.

SAS Statistical Programming Regulatory Validation Tableau QuickBase

Data Management Programmer

Actelion

Jan 2007 - Jan 2018 (11 years)

Developed reports and listings for data cleaning and checks, designed clinical databases and implemented narratives and protocol violation outputs to support data management activities.

Data Cleaning SAS SQL Data Management

Business Intelligence Analyst

Accenture Consulting Italia S.p.A.

Jan 2001 - Jan 2008 (7 years)

Led data warehouse analysis and reporting projects for telecom and retail clients, defined functional specifications, data models and integration interfaces, and supervised programming teams and feasibility assessments.