Andrés Malatesta, Biostatistician at Excelya        

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

Connect with Andrés Malatesta

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