Gaddoudi Olfa
@gaddoudiolfa
Seasoned Principal Clinical Programmer with expertise in statistical programming.
What I'm looking for
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
Principal Statistical Programmer
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.
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.
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.
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.
Education
Degrees, certifications, and relevant coursework
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.
Lycée 7 Novembre
Secondary School Diploma, Experimental Sciences
2008 - 2009
Grade: Graduated with Distinction
Achieved a Secondary School Diploma in Experimental Sciences, laying the groundwork for further studies in health sciences.
Availability
Location
Authorized to work in
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