Biostatistics and Statistical Programming Services
Pubrica’s biostatistical programming service delivers precise data analysis, advanced statistical modelling, and publication-ready outputs to ensure the accuracy, reliability, and scientific integrity of your research findings.
Ensure accurate and reliable study outcomes with Pubrica’s expert biostatistical programmers — delivering precise coding, advanced analysis, and rigorous validation to support your research and regulatory submissions
Pubrica delivers accurate, compliant, and publication-ready biostatistical programming for medical, life science, and healthcare research. With a team of certified SAS programmers and experienced biostatisticians, we have completed 150+ projects across therapeutic areas.
Our expertise in data management, advanced modeling, and regulatory adherence (FDA, EMA, ICH) ensures reliable study outcomes, submission-ready deliverables, and impactful research publications.
Advanced Biostatistics Consulting And CDISC-Compliant Statistical Programming
Reliable clinical trial data are essential for the success of any drug development program. Even groundbreaking therapies can be compromised by flawed study design or execution. At Pubrica, our expert biostatistical consulting team delivers meticulous data collection, validation, and analysis to ensure your research meets the highest standards. By providing end-to-end statistical support across every stage of drug development, we help you design efficient, cost-effective trials that minimize risk, optimize outcomes, and strengthen your path to regulatory approval.
Proficient in advanced methods
Our team excels in advanced statistical methodologies and adaptive clinical trial designs to modernize the delivery of biometrics consulting.
Integrated, end-to-end support
Capabilities covering all phases of drug development that closely link with pharmacometrics, clinical pharmacology, and regulatory solutions.
CDISC-compliant programming
Optimize your clinical trials with SDTM & ADaM dataset programming services, ensuring compliance and streamlined submissions.
Our Biostatistical Expertise Includes
We provide our researchers and clinical trials investigators with the Information, data management, analysis, and statistical interpretations they require:
- Data Management & Preparation – Cleaning, structuring, and validating datasets to ensure integrity and compliance.
- Statistical Programming – SAS, R, and customized coding solutions for clinical trial analysis and research projects.
- Advanced Biostatistical Analysis – Survival analysis, predictive modeling, regression techniques, and multivariate methods.
- Regulatory-Ready Deliverables – SDTM and ADaM datasets, tables, listings, and figures (TLFs) that meet FDA, EMA, and ICH guidelines.
- Customized Solutions – Tailored programming and modeling approaches aligned with specific therapeutic areas and research objectives.
- Comprehensive Reporting – Publication-ready statistical reports, visualizations, and interpretation to support manuscripts and submissions.
Who We Serve
Our biostatistical programming services cater to a diverse range of clients in the medical, pharmaceutical, and life science sectors, providing tailored solutions to meet their unique research and regulatory needs.
Pharmaceutical & Biotechnology Companies
End-to-end biostatistical and statistical programming support for clinical trials, from early-phase studies to post-marketing surveillance.
Clinical Research Organizations (CROs)
Flexible programming and analysis solutions that integrate seamlessly with CRO workflows and timelines.
Academic & Research Institutions
Statistical programming for academic research, grant projects, and publication-ready analyses.
Medical Device Manufacturers
Regulatory-compliant biostatistical programming for device trials, usability studies, and post-market evaluations.
Healthcare Providers & Hospitals
Data management, statistical analysis, and reporting for clinical research, patient outcome studies, and quality improvement initiatives.
Regulatory Agencies & Government Bodies
Submission-ready datasets, tables, listings, and figures (TLFs) that meet FDA, EMA, and ICH standards.
With expertise in SAS programming for clinical trials, CDISC SDTM and ADaM programming, and regulatory submission programming services, we ensure accurate, compliant, and submission-ready deliverables across multiple therapeutic areas.
Tools We Use
- Programming & Statistical Tools – SAS, R, STATA, SPSS, MATLAB
- Data Management & Standards – CDISC SDTM, ADaM, Pinnacle 21
- Visualization & Reporting – JMP, GraphPad, Power BI, Tableau
- Compliance Support – Tools aligned with FDA, EMA, and ICH regulatory requirements
How Our Biostatistical Programming Service Works
Our Step-by-step by Process
Requirement Gathering & Project Scoping
We begin by understanding your study objectives, therapeutic area, regulatory requirements, and preferred statistical methodologies. This helps us design a tailored programming strategy that aligns with your research goals.
Data Acquisition & Preparation
Our team collects and organizes raw datasets, performing data cleaning, transformation, and validation to ensure accuracy, completeness, and compliance with CDISC standards (SDTM, ADaM).
Statistical Programming & Analysis
Using advanced tools like SAS, we develop statistical programs for generating datasets, TLFs that support your SAP. This includes descriptive, inferential, and predictive modelling as per study requirements.
Quality Control & Validation
We implement rigorous QC checks to ensure programming accuracy, consistency, and minimize the risk of delays during regulatory review.
Reporting & Visualization
Our team delivers detailed statistical reports, visualizations, and submission-ready outputs that enhance data interpretation and decision-making for stakeholders.
Regulatory Submission Support
We provide regulatory submission programming services, ensuring all deliverables meet global compliance standards and are ready for submission to agencies like the FDA, EMA, and PMDA.
How We Help
- Streamline clinical trial data analysis with precise statistical programming
- Ensure data integrity and regulatory compliance across all stages
- Deliver publication-ready reports and visualizations for journals and stakeholders
- Provide end-to-end support from dataset preparation to submission deliverables
- Enhance research credibility with transparent, reproducible, and validated analyses
Our Compliance and Guideline Standards
At Pubrica, we follow internationally recognized standards and regulatory guidelines to ensure our biostatistical programming services are accurate, transparent, and fully compliant for global submissions.
CDISC Standards- SDTM (Study Data Tabulation Model) – Organizing and formatting collected clinical trial data for submission.
- ADaM (Analysis Data Model) – Structuring analysis datasets to align with the statistical analysis plan.
Regulatory Authority Guidelines- FDA (Food and Drug Administration – USA) submission standards.
- EMA (European Medicines Agency) data submission guidelines.
- PMDA (Pharmaceuticals and Medical Devices Agency – Japan) compliance requirements.
ICH Guidelines - ICH E9 – Statistical principles for clinical trials.
- ICH E3 – Structure and content of clinical study reports.
Data Privacy & Security Compliance- HIPAA (Health Insurance Portability and Accountability Act – USA).
- GDPR (General Data Protection Regulation – EU).
Software & Validation Standards
- SAS-compliant programming workflows with rigorous quality control (QC) and validation processes.
- Double programming and code review to minimize errors.
By integrating these compliance and guideline standards, we ensure that our clinical trial statistical programming, pharmaceutical biostatistics services, and regulatory submission programming services meet the highest level of quality and integrity, enabling faster and smoother regulatory approvals.
Biostatistics and Statistical Programming Services Sample Work
Download the full Report Now
Explore our biostatistical programming sample work, meticulously developed to comply with regulatory standards (e.g., FDA, EMA, PMDA), CDISC guidelines (SDTM, ADaM), and clinical trial timelines, ensuring accurate, submission-ready outputs for academic, clinical, and pharmaceutical research.
Biostatistical Programming Service – Our Packages
At Pubrica, we offer flexible and scalable biostatistical programming packages designed to meet the diverse needs of pharmaceutical companies, CROs, academic researchers, and life science organizations. Our packages are tailored to support projects at every stage of the clinical research lifecycle, from study design to regulatory submission.
Basic
Data Preparation & Cleaning
- Ideal for early-stage studies and exploratory research.
- Includes:
Data import, cleaning, and transformation
Basic descriptive statistical analysis
Dataset structuring to CDISC SDTM format
Data validation and QC checks
- Turnaround Time: 5–10 business days
Standard
Statistical Programming & Analysis
- Best for Phase I–III clinical trials and academic research projects.
- Includes:
SDTM and ADaM dataset creation
SAS programming for TLFs (Tables, Listings, Figures)
Statistical Analysis Plan (SAP) implementation
Quality control and double programming
Regulatory-compliant reporting
- Turnaround Time: 10–20 business days
Premium
End-to-End Biostatistical Support
- Comprehensive package for regulatory submission readiness.
- Includes:
Complete data management & programming lifecycle
SDTM, ADaM, Define.xml generation
Advanced statistical modelling and analysis
Submission-ready outputs for FDA, EMA, PMDA
Continuous support until regulatory feedback is addressed
- Turnaround Time: 20–30 business days
Custom
Tailored Solutions
- Designed for specialized projects or multi-country clinical trials.
- Includes:
Customized programming scripts and algorithms
Integration with the sponsor’s existing workflows
Therapeutic area-specific statistical methods
On-demand reporting and visualization
- Turnaround Time: Based on project scope
Testimonials
Learn how Pubrica’s biostatistical programming service has supported researchers, CROs, and pharmaceutical teams in producing accurate, regulatory-compliant analyses that strengthen clinical trial submissions and accelerate the path to approval. Here is what our clients say:
"Pubrica’s biostatistical programming team delivered high-quality, submission-ready datasets and analyses that met strict FDA and CDISC standards. Their attention to detail and proactive communication ensured our clinical trial data package was accepted without any queries."
— Dr. Emily Carter
Senior Biostatistics Manager, USA
"From data cleaning to final TLF generation, Pubrica’s biostatistical programmers were exceptionally skilled. Their knowledge of PMDA guidelines and their quick turnaround time helped us achieve regulatory approval faster than expected."
— Kenji Watanabe
Chief Scientific Officer, Japan
"Working with Pubrica was a seamless experience. Their expertise in SDTM and ADaM programming helped us meet EMA requirements ahead of schedule, and their validation process gave us complete confidence in the accuracy of our deliverables."
— James Whitmore
Director of Data Management, UK
Frequently Asked Questions – Biostatistical Programming Service
Our biostatistical programming services support:
- Pharmaceutical and biotechnology companies
- Clinical Research Organizations (CROs)
- Academic and research institutions
- Healthcare organizations
- Regulatory and government bodies
We use industry-standard platforms, including:
- SAS® (primary tool for clinical trial programming)
- R / R Studio for advanced statistical methods
- Python for automation and analytics
- SPSS, STATA for specific research and analysis needs
Depending on project requirements, we provide:
- SDTM and ADaM datasets
- Tables, Listings, and Figures (TLFs)
- Statistical Analysis Plans (SAPs)
- Programming validation reports
- Submission-ready datasets, documentation, and reports
Yes. Our biostatistical programming strictly adheres to:
- ICH E9 – Statistical Principles for Clinical Trials
- CDISC standards – SDTM and ADaM dataset creation
- FDA and EMA submission requirements
- 21 CFR Part 11 for data handling and programming
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