Ricardo Ferreira
Rua das Acácias, 342, Apto 502
São Paulo, SP 01234-567
(11) 98765-4321 | ricardo.ferreira@email.com | linkedin.com/in/ricardoferreira

PROFESSIONAL EXPERIENCE

Associate Director Biostatistics
Synergix Pharmaceuticals, Boston, MA
June 2021 - Present

• Lead biostatistical strategy and execution for Phase II/III oncology clinical trials, providing statistical expertise across protocol development, sample size determination, and interim analysis planning
• Manage team of 4 biostatisticians and programmers, overseeing statistical analysis plans, table/listing/figure specifications, and regulatory submission deliverables for multiple concurrent studies
• Collaborate with cross-functional teams including clinical operations, regulatory affairs, and medical affairs to ensure statistical rigor in study design and interpretation of efficacy and safety endpoints
• Author statistical sections of regulatory submissions including INDs, NDAs, and responses to FDA queries, contributing to successful approval of 2 oncology compounds
• Implement advanced statistical methodologies including adaptive designs, Bayesian approaches, and multiplicity adjustments to optimize trial efficiency and decision-making

Senior Biostatistician
Novara Clinical Research, Philadelphia, PA
March 2018 - May 2021

• Provided statistical leadership for Phase I-III clinical trials in oncology and immunology therapeutic areas, managing studies from protocol design through database lock and final reporting
• Developed statistical analysis plans and programming specifications using SAS, R, and Stata for complex clinical trial datasets including survival, time-to-event, and longitudinal analyses
• Conducted sample size calculations and power analyses for multiple trial designs including superiority, non-inferiority, and enrichment strategies
• Collaborated with data management teams to design case report forms, define edit checks, and validate clinical databases
• Presented study results to internal stakeholders and regulatory agencies, translating complex statistical concepts for non-technical audiences

Biostatistician II
Ascent Biosciences, San Francisco, CA
August 2015 - February 2018

• Performed statistical analyses for Phase II clinical trials using SAS and R, including descriptive statistics, hypothesis testing, and regression modeling
• Generated tables, listings, and figures for clinical study reports and regulatory submissions according to ICH guidelines and CDISC standards
• Collaborated with clinical programmers to develop and validate SAS macros for standardized analysis workflows
• Supported protocol development by providing input on statistical design, endpoint selection, and analysis methodologies
• Conducted literature reviews and meta-analyses to inform clinical development strategy and competitive landscape assessment

Biostatistician I
Precision Analytics Inc., New York, NY
July 2013 - July 2015

• Supported clinical trial statistical activities including data analysis, reporting, and quality control review
• Programmed statistical analyses using SAS and R for Phase I/II trials, ensuring compliance with regulatory standards
• Assisted in preparation of statistical sections for protocols, informed consent forms, and clinical study reports
• Performed data validation and quality checks on clinical databases using SQL queries
• Participated in internal audits and inspection readiness activities

EDUCATION

Doctor of Philosophy (Ph.D.) in Biostatistics
University of Michigan, Ann Arbor, MI
September 2008 - May 2013
Dissertation: Advanced Survival Analysis Methods for Censored Data in Clinical Trials

Master of Science (M.S.) in Statistics
University of Illinois, Urbana, IL
September 2006 - May 2008

Bachelor of Science (B.S.) in Mathematics
Federal University of São Paulo, São Paulo, Brazil
September 2002 - May 2006

SKILLS

Statistical Software & Programming: SAS, R, Stata, Python, SQL, MATLAB
Clinical Trial Design: Protocol development, sample size calculation, adaptive designs, interim analyses
Therapeutic Areas: Oncology, immunology, drug development
Regulatory Knowledge: FDA submissions, ICH guidelines, CDISC standards (SDTM, ADaM)
Data Analysis: Survival analysis, longitudinal data analysis, mixed models, Bayesian methods
Database Management: SQL, MySQL, clinical database validation
Additional Technical: Unix/Linux, C++, Java

ACHIEVEMENTS

• Led statistical strategy resulting in successful FDA approval of novel oncology therapy in 2023
• Published 12 peer-reviewed manuscripts in biostatistics and clinical research journals
• Presented at American Statistical Association and Society for Clinical Trials annual conferences
• Recipient of Synergix Pharmaceuticals Excellence in Statistical Innovation Award, 2022