Catalina Rodríguez
Calle 47 No. 12-35, Apartamento 8B, Bogotá, Colombia
+57 1 234 5678 | catalina.rodriguez@email.com | linkedin.com/in/catalinarodriguez

PROFESSIONAL EXPERIENCE

Principal Biostatistician
Pharmaceutical Research Analytics Solutions, Princeton, New Jersey
January 2019 – Present

• Lead statistical design, analysis, and reporting for Phase II-IV oncology and immunology clinical trials, ensuring regulatory compliance with FDA and EMA guidelines
• Develop and validate advanced statistical methodologies in R and SAS for adaptive trial designs, resulting in 30% reduction in sample size requirements while maintaining statistical power
• Mentor team of 6 biostatisticians and programmers, providing technical guidance on complex statistical analyses and regulatory submissions
• Collaborate with cross-functional teams including clinical operations, data management, and regulatory affairs to deliver 15+ successful NDA/BLA submissions
• Author statistical analysis plans, protocols, and clinical study reports for pivotal trials supporting drug approvals in oncology therapeutic areas

Senior Biostatistician
Clinical Biostatistics International, Boston, Massachusetts
March 2015 – December 2018

• Designed and executed statistical analyses for Phase I-III clinical trials across multiple therapeutic areas including oncology and immunology
• Developed SAS macros and R packages to automate routine statistical analyses and validation procedures, improving efficiency by 40%
• Served as statistical lead for 8 clinical studies, interfacing directly with regulatory agencies during pre-IND and end-of-Phase II meetings
• Conducted sample size calculations, randomization schemes, and interim analyses for adaptive trial designs
• Prepared statistical sections for regulatory submissions and responses to FDA/EMA queries

Biostatistician II
Quantitative Sciences Research Group, Philadelphia, Pennsylvania
June 2011 – February 2015

• Performed statistical programming and analysis for clinical trials using SAS and R in accordance with CDISC standards
• Created tables, listings, and figures (TLFs) for clinical study reports and regulatory submissions
• Validated statistical programs and outputs to ensure accuracy and compliance with SOPs and regulatory requirements
• Contributed to development of departmental programming standards and best practices documentation
• Supported CMC statistical analyses for process validation and quality control in pharmaceutical manufacturing

Statistical Analyst
Biomedical Data Solutions Inc., Baltimore, Maryland
August 2009 – May 2011

• Conducted statistical analyses for preclinical and early-phase clinical studies in life sciences research
• Developed SAS programs for data cleaning, transformation, and descriptive statistical analyses
• Generated summary statistics and graphical displays for study reports and scientific presentations
• Assisted in validation of analytical methods including GC-MS assays for pharmacokinetic studies
• Collaborated with laboratory scientists to design experiments and interpret statistical results

EDUCATION

Ph.D., Biostatistics
University of Michigan, Ann Arbor, Michigan
2007 – 2009

Master of Science, Statistics
Johns Hopkins University, Baltimore, Maryland
2005 – 2007

Bachelor of Science, Mathematics
National University of Colombia, Bogotá, Colombia
2001 – 2005

SKILLS

Statistical Programming: SAS Programming, R, Statistical Modeling, Survival Analysis, Bayesian Methods
Clinical Trials: Study Design, Sample Size Calculation, Adaptive Designs, Interim Analysis, Randomization
Regulatory: FDA/EMA Submissions, CDISC Standards (SDTM, ADaM), ICH Guidelines, GCP Compliance
Therapeutic Areas: Oncology, Immunology, Life Sciences, Pharmaceutical Industry
Technical: Validation, CMC Statistics, GC-MS Data Analysis, Programming, Data Visualization

CERTIFICATIONS

Certified Statistical Programmer (CSP), SAS Institute
Regulatory Affairs Certification (RAC), Regulatory Affairs Professionals Society

PROFESSIONAL AFFILIATIONS

American Statistical Association (ASA), Member
Society for Clinical Trials (SCT), Member
Biopharmaceutical Section of ASA, Active Member