STATISTICA MEDICA - Key Persons

Job Titles:

• Biostatistician
• Biostatistician in 2017 and Has Progressed to a Biostatistics & Programming
• Biostatistics & Programming Lead

Anna Pozzebon joined StatisticaMedica as a Biostatistician in 2017 and has progressed to a Biostatistics & Programming (B&P) Lead role. Anna has a Master's in Mathematical Engineering (Statistical Field) and a Degree in Mathematics, both from Politecnico di Milano, Milan, Italy. Anna has achieved an advanced level of qualification/certification in CDISC and SAS programming standards in addition to ongoing GCP certification since joining StatisticaMedica. Anna serves as the B&P Lead and is the primary client contact. In her role as B&P Lead, Anna manages multiple study timelines, resources, and quality deliverables in conjunction with the CEO. Responsibilities include the oversight and quality review of statistical outputs such as statistical sections of protocols, statistical analysis plans, statistical reports and validation reports prior to delivery to clients. She also oversees the review of the validation of analysis datasets, analysis outputs and tracking files. Anna liaises closely with client counterparts regarding study timelines and issue resolution. She coordinates project activities with external vendors for adherence to contract scope, timelines and quality deliverables. Anna also works closely with the study team to coordinate internal and external training. Prior to joining StatisticaMedica, Anna worked in Data Analytics at Amiko, Milan, Italy, a digital medicine platform provider.

Job Titles:

• Biostatistician
• Senior Biostatistician
• Lead Biostatistician for Assigned Projects

Athina Kranidi joined StatisticaMedica as a Biostatistician in 2020 and has since progressed to Senior Biostatistician. Athina has a Master's in Statistics with Applications in Medicine from the University of Southampton, UK and a Degree in Mathematics from the University of Athens, Greece. Athina has achieved an advanced level of qualification/certification in CDISC and SAS programming standards in addition to ongoing GCP certification since joining StatisticaMedica. Athina is Lead Biostatistician for assigned projects at StatisticaMedica, coordinating biostatistical activities internally and liaising with client counterparts regarding the ongoing status and delivery of projects. Athina's study responsibilities involve the programming and validation of analysis datasets (including CDISC SDTM and ADaM) and statistical outputs (e.g., tables, figures and listings) and power analyses. In addition, Athina reviews and provides input into study design, sample size calculations, the statistical section of study protocols and statistical analysis plans and conducts data quality control activities. Athina also provides guidance to junior employees. In addition to her project responsibilities, Athina supports the StatisticaMedica team in the delivery of Biostatistics Clinics for external academic researchers in various statistical methodologies, including mixed-effects models, linear/logistic regression analyses, sample size calculations and structural equation models. Prior to joining StatisticaMedica, Athina worked as a Biostatistician with CSTAR-UCD, Dublin and a Model Risk Analyst with Bank of Ireland, Dublin.

Job Titles:

• Consultant Medical Writer
• Freelance Medical Writer and Editor

Brigitte Scott is a very experienced freelance medical writer and editor who provides a high quality medical writing service to pharmaceutical and biotechnology companies, medical and scientific publishers, and public relations and healthcare communications agencies. She has collaborated with StatisticaMedica since 2016. Brigitte has a PhD in Biochemistry from King's College London and an honours degree in Biochemistry from the University of Bristol. She has over 25 years' medical writing experience in a contract research organisation, healthcare communications and freelance environment. Expertise in Clinical Research Brigitte's expertise is being able to write, review and edit a wide range of documents in many therapeutic areas for different target audiences. Her specialities include researching and writing medical books for consultants and GPs; producing press releases, infographics, slide kits, lectures and medical conference and meeting reports; preparing training manuals, product monographs, white papers, clinical study protocols, expanded access protocols, clinical study reports, patient narratives, clinical evaluation reports, investigator brochures, research papers and review articles; writing and editing peer review manuscripts; researching and writing key opinion leader interview articles, symposium review articles and independently commissioned articles, and creating and moderating podcasts and webinars.

Job Titles:

• Director of Biostatistics
• Member of the Royal Society for Statisticians

Under Gloria's leadership and strategic direction, StatisticaMedica continues to grow its Biostatistics and Consulting Services, with expertise in advanced statistical methods and study design. Gloria provides expert-level input and advice to sponsors on study design and regulatory requirements, including attendance at notified regulatory body meetings (FDA and EMA) in a Senior Biostatistician advisory role. As Director of Biostatistics, Gloria contributes at a senior level to various aspects of biostatistical design and analysis, overseeing the statistical validity of trial data and quality processes for deliverables. She provides strategic direction for company operations, including development of resource capacity and capabilities. Furthermore, Gloria provides strategic direction for innovative statistical methods for complex study design and novel therapeutic and diagnostic areas of analysis, e.g., use of simulation for in silico trials. Gloria is a Scientific Advisor to the EU IMI initiative and is a member of several Data Monitoring and Safety Committees for innovative drugs (e.g., for rare paediatric diseases) in the EU and US. Gloria served as Adjunct Professor at the Mathematical Theoretical Biology Institute (MTBI), Arizona State University, USA for one year. In this capacity, Gloria presented lectures and workshops in Biostatistics at the Graduate School and was Visiting Professor to the Graduate Summer Program at the MTBI. She was also Co-Principal Investigator on international research projects in statistics and mathematics applied to health research. In addition, for one year Gloria was Professor of Biostatistics and Director of the Data Science Centre at the Royal College of Surgeons of Ireland (RCSI). As Director of the new Data Science Centre, Gloria was responsible for setting up the statistical framework to provide statistical support to health research carried out within RCSI Ireland and internationally (Dubai, Bahrain and Malaysia). Gloria is a member of the Royal Society for Statisticians, a Chartered Statistician with CStat, a Fellow of the Royal Statistical Society, and a Chartered Mathematician with CMath. Gloria Crispino founded StatisticaMedica in 2012 and is CEO and Director of Biostatistics of the company. Gloria has a PhD in Biostatistics and Mathematical Biology from the Institute of Technology (ITT), Dublin, Ireland and a Bachelor of Economics (Statistics and Operational Research) from Bocconi University, Milan, Italy. Gloria Crispino PhD founded StatisticaMedica in 2012 and is CEO and Director of Biostatistics of the company. Gloria is expertly supported by an experienced core team comprising a research fellow, a senior operations manager, senior biostatisticians, biostatisticians, junior/trainee biostatisticians, and a consultant medical writer.

Job Titles:

• a Senior Data Scientist
• Junior Biostatistician
• Senior Data Scientist

Jack Lacey-Curtis joined StatisticaMedica as a Senior Data Scientist in 2022 and has since progressed to a Junior Biostatistician role. Jack has a Degree in Statistics and a Master's in Artificial Intelligence for Medicine and Medical

Job Titles:

• Biostatistician
• a Junior Biostatistician
• Junior Biostatistician

Laura Heaton joined StatisticaMedica as a Junior Biostatistician in 2022 and have since progressed to a

Job Titles:

• Biostatistician
• a Senior Data Scientist

Rishabh Bahl joined StatisticaMedica as a Senior Data Scientist in 2021 and has since progressed to a Biostatistician role. Rishabh has a Master's in Statistics from University College Dublin, Ireland and a Degree in Computer Science from University of New Delhi, India. Rishabh has achieved an advanced level of qualification/certification in CDISC and SAS programming standards in addition to ongoing GCP certification since joining StatisticaMedica. Rishabh supports the senior statistics team in the project management of assigned studies to ensure progress with respect to quality and study timelines. His study responsibilities involve the programming and validation of analysis datasets (including CDISC SDTM and AdaM) and statistical outputs (e.g., tables, figures and listings) and power analyses. Rishabh supports the development of study designs, sample size calculations, and statistical analysis plans, and conducts quality control activities. In addition, Rishabh provides guidance to new employees. Prior to joining StatisticaMedica, Rishabh worked for 3 years in various Business and Actuarial Analyst roles in Researchers Corporation Inc, London, and DHFL Pramerica Life Insurance, India.

Job Titles:

• a Junior Biostatistician
• Junior Biostatistician

Sinead M. Harrison joined StatisticaMedica as a Junior Biostatistician in February 2023. Sinead has a Master of Science in Data Science and Analytics from University College Cork, Ireland, a Degree in Applied Mathematics and an Honours Degree in Mathematical Statistics from University of Pretoria, South Africa. In line with StatisticaMedica's standards for new employee induction, Sinead is

Job Titles:

• Fellow
• Member of the Royal Society for Statisticians
• Member of the the Faculty Capacity Development Organisation
• Research / Fellow

As Research Fellow, Tim oversees the statistical validity of trial data and the quality processes for output validation at StatisticaMedica. Tim provides input and advises the study teams on topics such as methods for study design, analyses, and presentation of study results. He also contributes at a senior level to protocol development, writing statistical analysis plans (SAP), analysing study data, and writing statistical reports. Furthermore, Tim leads the development of innovative statistical methods for complex study designs and novel therapeutic/diagnostics areas of analysis, with emphasis on the use of simulation for in silico trials. He also supports health research initiatives utilising observational, qualitative, or evidence-based approaches. Tim has been a faculty member for the Faculty Capacity Development Organisation in Ireland for over 10 years, delivering online courses in Clinical Trials, Knowledge Management and Statistics, including short courses taught in Africa and planned for Asia and Central America. Tim is a member of the Royal Society for Statisticians, CStat and CSci, Statisticians in the Pharmaceutical Industry, and the American Statistics Association. Tim Grant joined StatisticaMedica in 2014 and worked closely with the CEO to develop the company into a specialised Biostatistical Clinical Research Organisation (CRO). Tim has an MS in Biostatistics from University of Wisconsin, USA, and a PhD in Education Psychology from University of Wisconsin, USA, an MS in Mathematics/Statistics from University of Texas, San Antonio, USA, and a BS and MS in Mechanical Engineering from Texas A&M University, USA.