Work experience

• Head of Biostatistics

  Acrturus Therapeutics

  2023.03-Current

  (3 years)

  Vice President Biostatistics · Global Head of Biostatistics, Statistical Programming and Data Management
• Vice President Global Biostatistics

  Pfizer

  2021.10-2023.03

  (a year)

  · Global Head of Biostatistics – Oncology early clinical development · Leadership and strategic directions of the global Biostatistics platform · Represents Biostatistics organizationally within corporate environment in order to enable successful impact on clinical development · Managing the oncology statistical group (10-12 statisticians; locations: La Jolla- San Diego (CA), Cambridge (MA), Boulder (CO))
• Executive Director Biostatistics

  Pfizer

  2017.06-2021.10

  (4 years)

  · Global Head of Biostatistics – Oncology early clinical development · Coordinate all statistical activities at the asset level and clinical trial level from Dose Finding to POC · Managing the oncology statistical group (10-12 statisticians; locations: La Jolla- San Diego (CA), Cambridge (MA), Boulder (CO)) · Leading statistical initiatives · Bayesian Designs: Develop strategies for combination of investigational agents. Phase 1 dose-escalation-selection for combinations. · Develop strategies for patient selection in phase 1 and 2 clinical trials. Phase 1 expansion cohort adaptation. Biomarker adaptive designs and adaptive randomization. · Immuno-oncology clinical endpoints · Develop sample eCRF tracking and data transfer processes for biomarker samples · Interaction with Regulatory Agencies (eg FDA, PMDA, EMA)
• Snr Director Biostatistics

  Pfizer

  2015.04-2017.06

  (2 years)

  · Statistical support for clinical development of Immuno Oncology and Therapeutic Cancer Vaccines. Application of Decision Theory and Adaptive Design to expedite clinical development. · Group Head (3 statisticians) immuno oncology early development statistics
• Director Biostatistics

  Pfizer

  2012.04-2015.04

  (3 years)

  · Responsible for statistical aspects of clinical development plans: Early Development Oncology, Personalized Medicine, Oncology Immunotherapy and Therapeutic Vaccines.
• Assoc. Director Biostatistics

  Novartis Oncology

  2010.04-2012.04

  (2 years)

  Oncology Biostatistics · Discovery, Development and Analysis of Biomarkers in Oncology · Provide high quality and timely statistical support to enhance the integration and impact of biomarker & imaging data on the clinical development of compounds within the oncology portfolio · Integration of personalized medicine · Support molecular diagnostics and “companion diagnostics” activities · Development of SOPs and Guidelines for Biostatistics, Statistical Reporting and Data management · Managing a team of biomarker and clinical statisticians, programmers and data managers in Oncology Translational Medicine · Group of 3 statisticians, 2 statistical programmers and 1 data manager.
• Principal Biostatistician

  Genomic Health, Inc

  2007.06-2010.04

  (3 years)

  · Design and development of statistical methodology and study design clinical trials (Oncology – Breast Cancer). · Statistical support for presentations and publications · Algorithm development, Prognosis, Prediction of cancer Genes and Gene interactions with cancer treatments, Analysis of biomarkers, Flexible log cumulative hazard functions and Fractional Polynomial Regression. Evaluation, assessment and calculation of sample size and statistical power. · Design and analysis of observational studies using survival analysis as well as clinical and genetic epidemiology methods. Case-Control and Nested Case-Control studies, Cohort Sampling, Weighting, False Discovery Rate, Supervised and Unsupervised methods with Cross-Validation.
• Cluster Biostatistician

  Novartis Vaccines & Diagnostics (formerly Chiron)

  2005.12-2007.05

  (a year)

  Biostatistician
• Project Biostatistician

  Chiron Vaccines

  2001.09-2005.10

  (4 years)

  · Provide statistical input to clinical development plans · Responsible for statistical aspects of projects, including experimental design, analysis, and presentation of data. Phase I-II-III-IV clinical trials. Superiority and non-inferiority, efficacy and safety objectives. · Regulatory Submissions and interactions with Regulatory Agencies (e.g. BLA, IND, EOPII, Scientific Advice, EU centralized and decentralized) · Ensure appropriate wording of the primary and secondary objectives and statistical hypotheses, statistical sample size, power calculations, and selection of statistical analysis methodology. · Medical Affairs: collaboration with external KOL, co-author presentations and publications · Provide technical/statistical reports on the data for review by the report writing team · Meet with internal and external non-statistical colleagues and provide statistical consulting. · Provide training to internal and external customers on statistical issues in biomedical research
• Statistician

  (ISS) Italian National Institute of Public Health - Rome, Italy

  1998.04-2001.09

  (3 years)

  AIDS and Sexual Transmitted Diseases Statistician Statistician · Develop statistical analysis plans, statistical analyses and statistical reports · Collaborate with stat analyst on defining and creating derived variables. · Provide an active collaboration in the paper (international publications) writing process. · Provide statistical input in Clinical Epidemiology, Quantitative Epidemiology and Genetic Epidemiology, Case-Control studies, Cohort studies · In vitro and in vivo pre-clinical analyses and bioequivalence studies. Process validation, assay validation, and assay and bioassay development.

Educational experience

• university of rome "la sapienza"

  Laurea in Statistics

  1992.09-1998.03

  (6 years)

  Biostatistics
• "g. vallauri" institute of rome

  Computer Science

  1987.09-1992.07

  (5 years)

  High school student computer science

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