Excelya Author
Andrés Malatesta
Biostatistician at Excelya
Professional Perspective
Transforming complex clinical data into meaningful evidence
Biostatistician and statistical programmer with over six years of experience in clinical research, including two years at Excelya. He has contributed to more than a dozen clinical trials and real-world evidence studies across multiple therapeutic areas, including oncology, endocrinology, and psychotherapy.
Andrés has led programming teams of more than 10 specialists on Phase IV and real-world evidence oncology projects, delivering single-study and pooled analyses that supported regulatory submissions and strengthened collaboration with sponsors and cross-functional stakeholders.
He is the author of multiple peer-reviewed publications, including two full research articles and three conference abstracts. At Excelya, he is passionate about helping clients transform complex clinical data into meaningful evidence through rigorous statistical methodologies that support regulatory decision-making and improve patient care.
Areas of Expertise
Biostatistics and statistical programming
01
Biostatistics
Statistical Analysis Plan (SAP) development
TLF shell design
Time-to-event analyses
Regression modeling
Randomized controlled trials (RCTs)
Observational study designs
Statistical results quality control (QC)
Clinical Study Reports (CSRs) and scientific publications writing
02
Statistical Programming
SAS programming
R programming
CDISC submission package creation
SDTM and ADaM implementation
CRF annotation
Dataset and TLF development for regulatory submissions
Programming quality control and validation
Professional Profile
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Explore Andrés’ professional background and experience in biostatistics, statistical programming, clinical research, real-world evidence, and regulatory submissions.
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Biostatistics • Clinical Research