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Expert Biostatistics & Statistical Programming Services
We provide expert biostatistics services and statistical programming to ensure your submissions meet regulatory requirements and publication standards.
Biostatistics & Statistical Programming for Research
Statistical Intelligence for Informed, Compliant, and Timely Decisions
Biostatistics and statistical programming services from Statswork solutions offer data security and regulatory knowledge to help you work out in various complexities such as trial design, randomization, statistical analysis plan, statistical programming, clinical study report generation, sample size, data displays and interpretations across a broad range of therapeutic areas, supported by robust processes.
Our biostatistics and statistical programming outsourcing services share the equal risks and responsibility of your firm, by forming a long-term strategic relationship that is integral to your organization’s overall business plan, supporting clinical trial data analysis, clinical research statistics, data management, clinical trial programming, and statistical analysis.
Over the years, we have assisted a multitude of organizations, empowering them with feasible solutions using sophisticated statistical analysis and analytical modelling tools. Our flexible embraced business models, along with our deep industry knowledge and capabilities, we ensure to deliver significant benefits in operational efficiency and costs reduction through our analytical services.
In today’s data-driven research and healthcare ecosystem, statistical programming and biostatistics services are core pillars of scientific accuracy, regulatory compliance, and evidence-based decision-making. Whether you’re evaluating treatment efficacy, optimizing clinical trial design, or analysing public health data, these disciplines transform raw datasets into actionable insights. With the rapid growth of electronic health records (EHRs), real-world evidence (RWE), and large-scale clinical trials, demand for advanced statistical programming and biostatistical consulting services is at an all-time high. SAS programming for clinical trials and clinical trial data management services are essential components of this evolving landscape.
Biostatistics in clinical research ensures accuracy and reproducibility by applying appropriate models and techniques, limiting errors with expert biostatistical consulting services.
Automation in statistical programming reduces manual work, saving time in analysis, reporting, and publishing, supported by Epidemiological data analysis.
Proper documentation of statistical analysis ensures compliance with FDA, EMA, and other regulatory requirements.
Statistical methods have the possibility of addressing issues relating to outliers, substituting prospective missing data, and accounted for biases which may promote veracity in results.
COVID-19 Vaccine Trials
During the process of developing the COVID-19 vaccines, biostatistics services and biostatistical modelling were indispensable in the design of adaptive clinical trials, estimating vaccine efficacy, and conducting interim safety analysis—this allowed expedited access to a regulatory approval process.
Pharmacovigilance in Drug Safety
Large scale pharmaceutical companies use automated statistical programming pipelines for drug safety monitoring of adverse drug events across populations, identifying safety signals using a Bayesian and frequentist approach.
Genomic Data Interpretation
Clinical trial data analysis and Biostatistics plays an important role in the analysis of genome-wide association studies (GWAS), where millions of genetic variants are tested for associations with disease. This type of analysis is conducted in conjunction with software programs such as Python and R which allow for the management and visualization of such high dimensional data.
At Statswork we provide a complete end-to-end solution through our biostatistics services and statistical programming for clinical trials, epidemiological studies, and academic research (proof of concept, pilot studies). We can provide services that are scientifically rigorous, comply with regulatory requirements and data-driven from validated methodologies, and can provide cross-platform programming capabilities and interface.
Analysis
Analysis
Epidemiological Analysis
Analyses of observational, cohort, case-control, diagnostic and prognostic studies.
Clinical Trial Analysis (Phase I–IV)
Analytics of drug trials across all therapeutic areas (oncology, CNS, CV, dermatology, endocrinology).
Meta-analysis & Systematic Review
We produce your PRISMA-compliant meta-analyses using RevMan, Metafor, or any other advanced analysis tool.
Protocol & SAP Development
Professional review and development of protocols and SAPs, including the development of all endpoints, randomization and power calculations.
We work with clients in the fields of pharmaceuticals, public health, medical devices, and academic institutions. Statswork combines the skill and understanding of industry-science with technical expertise to ensure that your data is consistent with analytical expectations and is compliant with scientific, regulatory, and business considerations.
Our Industries
At Statswork we work with organizations to reduce costs, increase efficiencies, and enhance customer service using advanced artificial intelligence and machine learning algorithm development.Â
At Statswork, our primary function is to provide outsourced statistical programming and biostatistics consulting services for organizations that need precision, compliance, and scale in their research infrastructure. Our support is uniquely designed for businesses, CROs, healthcare organizations, and academic institutions to accelerate their development cycle and ensure data integrity and regulatory compliance.
- Scalable statistical programming on multiple studies.
- CDISC standards, ADaM datasets, regulatory reporting.
Biostatistical input and contribution for protocol design, SAP development, and interim analysis.
- Full-service biostatistics outsourcing for clinical phase I–IV.
- Pharmacokinetics/pharmacodynamics (PK/PD), dose-response modeling .
End-to-end submission support (CSR, FDA/EMA/NICE-compliant TLFs).
- Real-world data (RWD) and health economics & outcomes research (HEOR) analysis.
- Epidemiology studies, observational study analysis, survival modelling.
Expert assistance for guideline-compliant meta-analyses (PRISMA, STROBE, STARD).
- Statistical modeling for clinical validation and regulatory submissions.
- Consultation for study design (RCTs, cross-over studies, cohort studies)
- Use of Bayesian models, simulation-based designs, and ROC analysis.
- Partner based funding for research, collaboration and publication.
- Customized support and training for SAS, R, Python, SPSS for internal teams.
- Biostatistical expertise for multi-site, interdisciplinary research collaborations.
- Algorithm validation, predictive modeling, and analytics driven by AI.
- Statistical design and validation of mobile health (mHealth) or telehealth tools.
- Clinical data analytics to support product-market fit, trials or pilots
We can do more
Advance your research with trusted biostatistics and statistical programming.Â
At Statswork, our statistical programming and biostatistics services provide customization by domain to ensure appropriateness, compliance, and accuracy of results.
Healthcare & Clinical Research
We conduct biostatistical support and clinical programming for randomized controlled trials (RCTs), observational studies, epidemiological surveys, and health outcomes analysis. We provide support for the protocol, develop SAPs, generate TLFs, and complete regulatory submissions (ICH-GCP compliant).
Public Health & Epidemiology
We provide industry-leading biostatistical analysis for public health and epidemiology through national health surveys, disease tracking models, and evaluating the impact of public health interventions. We provide modeling of population health data and provide examples of risk estimations based on real-world health records (like databases in source of health organizations).
Pharmaceutical & Life Sciences
We offer biostatistical support and clinical programming for clinical studies/pharmaceutical formulation packages. We perform Epidemiological biostatistics across clinical development programs (phases I-IV), including interim analysis, dose-response modeling, survival analysis, and clinical regulatory datasets including CDISC format.
Social Science & Psychology
We perform descriptive, inferential, and non-parametric analyses on surveys, behavioral data, and experimental data in visual analytic environments using SPSS, R, and STATA
Academic Research & Publications
We support research scholars by providing the complete pipeline for research including hypotheses, data analysis, data interpretation, data visualization, and publication.
End-to-End Biostatistics & Statistical Programming Workflow – From Study Design to Submission-Ready Reporting
1. Requirements Gathering and Project Scoping
- Client onboarding & signing NDA
- Protocal, objectives and regulatory requirements review
- Clarify data sources, therapy area, study phase, and endpoints
- Deliverables, timelines, tool (SAS, R, Python, SPSS), report format
2. Study Design Consultation & SAP Development
- Identify & recommend appropriate study design (parallel, crossover, observational, etc)
- Develop or review Statistical Analysis Plan (SAP) in accordance with ICH E9 regulations
- Identify distinct analysis populations (e.g., ITT, PP), endpoints and analysis strategy
- Provide estimated sample size and power using accepted methodology
3. Data Management & Programming Setup
- Data cleaning, pre-processing, and validation of raw datasets
- Development of analysis-ready datasets (ADaM)
- Create standard macros and validated statistical programs
- Create reproducible programming workflows using tools specified by the client
4. Statistical Analysis & Modeling
- Summarize descriptive statistics, conduct inferential testing, and provide multivariate models
- Implement advanced statistical methodology: Bayesian modeling, mixed-effect model, survival modelling, logistic regression, etc.
- Provide interim, subgroup, and/or sensitivity analysis as per SAP
5. Reporting: TLFs & Regulatory Submissions
- Develop Tables, Listings & Figures (TLFs) according to CDISC / FDA / EMA guidelines
- Provide submission-ready reports: clinical study reports (CSR), appendices, summary outputs
- Conduct quality control (QC) by sponsoring independent programmer/statistician according regulatory standards
- Provide version-controlled reporting with an audit trail history
6. Review, Delivery & Post Submission Support
- Internal preliminary reviewing process including: Technical, Statistical, and Compliance Check
- Provide client review and unlimited revisions within scope
- Provide regulatory questions, manuscript writing or publication support
- Provide metadata and annotated outputs for potential audits and/or future submissions
"Statswork provided smooth statistical programming for our Phase III clinical trial project, and ensured compliance to CDISC standards. Their deep knowledge of SAS programming and appreciation of global regulatory standards meant that submitting to the FDA was without fuss. We will certainly be working together on our next trial."
— Clinical Trial Statistical Programming
— Senior Biostatistician, Global Pharmaceutical Company
"Our complicated epidemiological dataset required more than just the plugging in of standard statistics. Statswork offered us advanced survival modelling and improved our overall analysis workflow. Statswork's consultative approach and level of knowledge in biostatistics brought credibility and clarity to our findings.''
Advanced Analytics in Public Health Research
-Principal Investigator, Public Health Research Institute
" We wrestled with unstructured real-world evidence from electronic health record data. We hired Statswork to clean the data and turn it into matched, analytic-ready datasets.And they generated automated, report-ready reports for regulators. They added serious value to our HEOR submission and saved us internal project hours with higher reliability."
Real-World Evidence and HEOR Analysis
- Director of Health Economics and Outcomes Research for a Biotech Startup
"Statswork supported our investigator-led academic clinical trial with very rapid turn-around and powerful statistical insight. They transformed our unstructured clinical data, completed all requested statistical tests and assisted in shaping a publication-ready statistical report. Their service was speedy and clear."
University-based Medical Research
- Research Fellow, Academic Medical CenterWhy Statswork?
We combine statistical rigor with appropriate programming workflows, which is an important part to help ensure your research data, becomes valid, high-impact insights.
- Two – three domain experts involved on each project
- Regulatory-grade coding and documentation
- Secured data and NDA-protected
- End-to-end control of your project from design to delivery
- Scalable team of specialists with efficient turnaround time
AI & ML
Predective Analyses
Data Analyses
We help with randomized controlled trials, observational studies, epidemiological surveys, health outcomes research, submissions to regulators, and studies in a wide-ranging body of study types.
Yes. All services provided are compliant with 21 CFR Part 11, ICH-GCP considering global compliance such as FDA or EMA.
We support all platforms including SAS, R, SPSS, Python, STATA or MATALB, which allows flexibility for clients.
Yes. Our services provide complete end-to-end services from statistical analysis plans (SAP) , protocol, TLFs, interpretation, reporting or publication.
We are highly skilled in the fields of oncology, cardiology, neurology, endocrinology, dermatology, etc.
Yes. We embrace flexibility with service providers including FSPs, full-service outsourcing, and on demand consulting.
Yes. We create and validate CDISC-compliant datasets to help you get your regulatory review completed in a timely and compliant manner.
Our cross-functionally trained team has biostatisticians and programmers who have subject matter expertise and been involved in complex, multi-phase studies.
Yes. We support multiple academic researchers and institutions providing data analysis, data interpretation, and publication support.
We provide regulatory insights; statistically relevant results; and domain expertise into a single engagement model, and with our flexible engagement models, we aim to help our clients get high quality, submission-ready statistical options designed for your specification.
Let's Build Together
Are you making the most out of your clinical or research data? If you are ready to unlock the full value of your data, Statswork’s expert statistical programming and biostatistics services can help! We help you with trials, observational studies, and real-world data with precision, compliance, and insights.
