Senior biostatistician with more than 10 years of international experience supporting Phase I-IV clinical trials, observational studies, real-world evidence (RWE), and multinational epidemiological research across North …
Senior biostatistician with more than 10 years of international experience supporting Phase I-IV clinical trials, observational studies, real-world evidence (RWE), and multinational epidemiological research across North America, Europe, and Australia. Experts in statistical methodology, protocol development, SAP authoring, sample size determination, adaptive and longitudinal study designs, Bayesian and Survival analyses, and regulatory-quality statistical programming using SAS and R. Proven leader of multidisciplinary statistical teams with an extensive publication record and experience translating complex clinical data into evidence that informs regulatory, clinical, and commercial decisions.
<p>Interrupted time series<br>
Cluster randomized designs<br>
Systematic reviews and Meta-analysis<br>
Tools / Software: SAS macros, SAS SQL, SAS Stats, SAS graphs, SAS proc, R, STATA, SPSS</p>
<p>Implemented machine learning algorithms to identify high-risk patient cohorts and prescription management.<br>
Develop predictive models to identify biomarkers of cardiovascular diseases.<br>
Research focused on survival analysis and longitudinal data models in clinical settings to manage heart valve cells.<br>
TAVI research project. A European multicentre validation study of the accuracy of E/e’ ratio in estimating invasive left ventricular filling pressure (Survival data).<br>
Tools / Software: SAS macros, SAS SQL, SAS Stats, SAS graphs, SAS proc, R, SPSS.</p>
<p>Designed and analyzed clinical trials for a variety of therapeutic areas, including oncology, cardiology, and infectious diseases.<br>
Protocol review, SAP development, TLFs specifications.<br>
Developed statistical models to predict patient outcomes, improving the efficiency of clinical trial design.<br>
Contributed to the preparation of regulatory submissions, presenting statistical findings to regulatory agencies.<br>
Increased the efficiency and speed of data analysis processes through the implementation of new statistical software.<br>
Tools / Software: SAS macros, SAS SQL, SAS Stats, SAS graphs, SAS proc, SAS Entreprise G.</p>
<p>Lead statistical analyses for funded and non-funded clinical and observational studies.<br>
Supported grant proposals and power / sample size calculations.<br>
Designed statistical sections for manuscripts and protocols.<br>
Supervise junior statisticians and medical students.<br>
Co-authored 20+ peer-reviewed publications.<br>
Tools /Software: SAS macros, SAS SQL, SAS Stats, SAS graphs, SAS proc, SAS Entreprise guide, R, Python.</p>
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