10/26/2026 updated
100 % available
Principal Statistical Programmer | CDISC & SAS/R | Clinical Trials
San Juan de Alicante, Spain
Only remote
Master of Science (M.Sc.) in Geographic Information Systems and TechnologiesAbout me
Statistical Programmer with 10+ years of experience supporting Phase I–IV clinical trials, with strong expertise in SAS programming, CDISC standards, SDTM/ADaM, TLFs, regulatory submission deliverables, and working knowledge of R.
Clinical TrialsR (Programming Language)SAS (Software)SAS/STATCDISC Standards
SAS Programming
Expertise in SAS Suite including Base, MACRO, STAT, SQL, ODS, and GRAPH for developing, programming, and validating complex clinical trial datasets and analysis outputs across Phase I-IV studies.
CDISC & Regulatory Standards (SDTM/ADaM)
Deep knowledge of CDISC standards including SDTM and ADaM dataset development, Define.xml metadata creation, SDRG and ADRG authoring, and Pinnacle 21 validation for FDA/EMA regulatory submissions.
Clinical Trial Deliverables (TLFs)
Extensive experience producing Tables, Listings, and Figures (TLFs), CRF annotations, dataset specifications, double programming validation, and data transfers to support clinical study report deliverables.
R Programming
Working knowledge of R (tidyverse, admiral, ggplot2) for data manipulation, analysis and visualization in clinical trial contexts; actively expanding R skills alongside core SAS expertise.
Study Lead & Project Management
Experience as Study Lead overseeing resource and workload coordination, managing project scope, timelines, and delivery milestones across global pharma and CRO environments.
Quality Control & Double Programming Validation
Execution of rigorous QC frameworks and double programming validation achieving full compliance with CDISC standards and client SOPs.
Reusable Macro Automation
Design and deployment of standardized, reusable SAS macros to optimize setup speed and ensure code consistency across project streams.
GCP & ICH Compliance
Thorough understanding of GCP and ICH guidelines, SOP alignment, and audit/inspection readiness within clinical programming environments.
Therapeutic Area Expertise:
Broad therapeutic experience spanning Oncology, Hematology, Rare Diseases, Gene Therapy, Neuroscience, Psychiatry, Immune-Mediated, Respiratory, CardioMetabolic, Infectious Disease, Ophthalmology, and Dermatology across multiple clinical phases.
Experience
Professional experience10+ years
Freelancer since2025
Languages
EnglishFluentPolishGoodSpanishGood
Project history
Delivering high-impact freelance/contract statistical programming services for Phase I-IV clinical trials across global pharma and CRO clients. Developing, programming, and validating complex SDTM and ADaM datasets alongside TLFs to support regulatory submission readiness (FDA/EMA). Executing rigorous QC and double programming validation frameworks achieving 100% compliance with CDISC standards and client SOPs. Collaborating with cross-functional teams including Biostatisticians, Data Managers, and Clinical Operations leads.
Served as Technical Lead for SDTM activities across assigned clinical studies, overseeing study timelines, team resource allocation, and core technical deliverables. Created detailed SDTM dataset specifications, Define.xml metadata, and Study Data Reviewer Guides (SDRG) compliant with CDISC requirements. Designed and deployed standardized, reusable SAS macros to optimize setup speed and code consistency. Managed direct client communications and technical alignment between internal programming teams and biostatistics counterparts.
Led statistical programming activities for global Phase I-IV trials, managing project scope, quality control, and strict delivery milestones. Authored comprehensive SDTM/ADaM specifications, reviewed Statistical Analysis Plans (SAPs) and TFL shells from a programming feasibility perspective. Engineered ADaM datasets and highly specialized analysis outputs for complex oncology and rare disease studies. Generated and verified submission artifacts including Define.xml, ADRG, and Pinnacle 21 validation report issue resolution. Mentored junior and senior programmers, establishing SOPs and QMS alignment under GCP.