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Gaddoudi Olfa

@gaddoudiolfa

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Seasoned Principal Clinical Programmer with expertise in statistical programming.

Belgium

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What I'm looking for

I seek a role that allows me to lead programming teams and innovate solutions in clinical trials.

I am a seasoned Principal Clinical Programmer with over 9 years of experience in statistical programming within leading pharmaceutical companies. My expertise lies in SAS®, CDISC (SDTM, ADaM), and programming leadership across Phase I–IV trials. I am adept at macro development and advanced analytics, consistently delivering innovative programming solutions that enhance efficiency and support data-driven decision-making.

Throughout my career, I have led statistical programming for global clinical trials, ensuring timely and regulatory-compliant deliverables. My role at GlaxoSmithKline has allowed me to manage programming resources effectively, oversee deliverables, and improve programming workflows through the development of reusable macros. I am passionate about mentoring teams and fostering technical excellence, aiming to advance industry standards in clinical programming.

Experience

Work history, roles, and key accomplishments

Current

Principal Statistical Programmer

Current

GlaxoSmithKline

Jun 2021 - Present (4 years)

Led statistical programming for global clinical trials, ensuring timely, high-quality, and regulatory-compliant deliverables. Managed programming resources, oversaw deliverables, and improved workflows by developing reusable macros. Ensured full CDISC compliance supporting submission-ready datasets.

CDISC Statistical Programming Regulatory Compliance Quality Clinical Trials

Senior Statistical Programmer

GlaxoSmithKline

Feb 2016 - Jun 2021 (5 years 4 months)

Programmed and validated TFLs for regulatory submissions, drove CDISC implementation, and contributed to data interpretation and reporting. Ensured quality and consistency of study deliverables aligned with clinical objectives.

CDISC Regulatory Submissions Quality

Biostatistician

Novartis

Aug 2015 - Jan 2016 (5 months)

Led statistical planning and execution for early-phase oncology trials, supporting protocol optimization. Presented innovative statistical approaches at the Novartis Biostatistics Conference and delivered exploratory analyses for biomarker strategies.

Statistical Planning Oncology

Biostatistician

Biotronik

Feb 2015 - Apr 2015 (2 months)

Conducted statistical analysis for a Phase IV trial assessing Clexane®’s effect on venous thrombosis prevention. Generated insights through survival analysis and authored a comprehensive statistical report supporting hospital performance review.

Statistical Analysis Survival Analysis

Education

Degrees, certifications, and relevant coursework

Google

Project Management Professional Certificate, Project Management

2023 - 2023

Completed the Google Project Management Professional Certificate, enhancing skills in project management methodologies and practices.

SAS Institute

SAS Certified Base Programmer for SAS 9, Statistical Programming

2015 - 2015

Grade: Score: 73%

Achieved SAS Certified Base Programmer for SAS 9 certification, demonstrating proficiency in SAS programming and data analysis.

Université Libre de Bruxelles

Master’s in Biostatistics, Clinical Research & Epidemiology, Biostatistics

2012 - 2015

Grade: Graduated with Distinction

Graduated with Distinction in Master's in Biostatistics, Clinical Research & Epidemiology, focusing on statistical methods and their applications in clinical research.

Ecole des Sciences et Techniques de la Santé de Tunis

Bachelor’s Degree in Anesthesia & Intensive Care, Anesthesia & Intensive Care

2009 - 2012

Grade: Graduated with Distinction

Graduated with Distinction with a Bachelor's Degree in Anesthesia & Intensive Care, providing a strong foundation in medical sciences and patient care.