SAS Programming & Statistical Programming
Delivering CDISC-compliant datasets, tables, listings, and figures that meet the exacting standards of global regulatory authorities. Our statistical programming team combines deep domain expertise with rigorous quality processes to produce submission-ready deliverables for FDA, EMA, PMDA, and other regulatory agencies worldwide.
Expert SAS Programming for Clinical Trials
MTK Pharma Services maintains a dedicated team of senior SAS programmers with an average of 15 to 20 years of industry experience across all phases of clinical development. Our programmers have direct experience supporting regulatory submissions to the FDA, EMA, PMDA, and other global health authorities, ensuring your data tells a clear, compliant, and compelling story.
From SDTM mapping and ADaM dataset creation through TLF generation and define.xml development, our team delivers end-to-end statistical programming services that are fully aligned with CDISC standards, regulatory expectations, and your specific study requirements. Every programme undergoes independent quality control and Pinnacle 21 validation before delivery.
End-to-End Statistical Programming
Eight core programming capabilities covering every stage of the clinical data lifecycle, from SDTM mapping through submission-ready package assembly, delivered with independent quality control at every step.
SDTM Mapping & Programming
Comprehensive SDTM implementation fully compliant with the latest SDTM Implementation Guide, transforming raw clinical data into standardised regulatory-ready datasets.
- SDTM IG compliant mapping specifications
- CDISC controlled terminology implementation
- Supplemental qualifier (SUPP--) datasets
- Annotated CRF development
- Pinnacle 21 validation and issue resolution
ADaM Dataset Development
Analysis-ready ADaM datasets developed in strict accordance with the ADaM Implementation Guide and aligned with the Statistical Analysis Plan for seamless downstream analysis.
- ADaM IG compliant dataset structures
- ADSL (Subject Level) datasets
- ADAE (Adverse Events) datasets
- ADTTE (Time-to-Event) datasets
- BDS (Basic Data Structure) datasets
Tables, Listings & Figures
Publication-quality TLF outputs for Clinical Study Reports, interim analyses, DSMB meetings, and regulatory submissions with rigorous independent verification.
- Automated TLF generation workflows
- Publication-quality formatted outputs
- CSR appendix tables and listings
- DSMB and interim analysis outputs
- Integrated summary tables (ISS/ISE)
Define.xml Development
Complete define.xml generation with comprehensive metadata management, ensuring regulatory reviewers can navigate and understand your submission datasets efficiently.
- Define.xml 2.0 standard compliance
- Comprehensive metadata management
- Reviewer's guide authoring
- Value-level and variable-level metadata
- Controlled terminology cross-referencing
Submission-Ready Packages
Complete regulatory submission packages structured for eCTD filing, validated with Pinnacle 21 Community and Enterprise tools, ready for global health authority review.
- eCTD-compliant folder structure
- Pinnacle 21 validation and resolution
- FDA submission compliance
- EMA and PMDA submission requirements
- Dataset packaging and transport files
Independent Programming & QC
Rigorous double-programming methodology with independent verification to ensure the accuracy, completeness, and reproducibility of every deliverable.
- Double programming methodology
- Independent verification by senior staff
- Automated reconciliation processes
- Discrepancy tracking and resolution
- Comprehensive QC documentation
Integrated Summaries
Cross-study programming for Integrated Summaries of Safety (ISS) and Efficacy (ISE), pooled analyses, and long-term safety evaluations supporting NDA and BLA submissions.
- ISS and ISE programming
- Pooled analysis dataset creation
- Long-term safety data integration
- Cross-study data harmonisation
- Meta-analysis dataset support
Legacy Data Migration
Conversion of historical and legacy clinical trial data into CDISC-compliant SDTM and ADaM formats, enabling inclusion in pooled analyses and modern regulatory submissions.
- SDTM conversion from legacy formats
- Historical data standardisation
- Legacy-to-CDISC mapping specifications
- Data quality reconciliation
- Retroactive define.xml creation
Flexible Delivery Models
Choose the engagement model that best fits your programme needs, from full-service project delivery to embedded dedicated teams, with the flexibility to scale as your pipeline evolves.
Full-Service
End-to-end project ownership from SDTM mapping through submission package delivery. Our team manages the complete programming lifecycle, including timelines, quality control, and regulatory validation, so you can focus on your development strategy.
- Complete project ownership and delivery
- Dedicated project lead and programming team
- Integrated QC and validation workflows
- Milestone-driven timelines and reporting
- Regulatory submission support
Functional Service Provider (FSP)
Dedicated, named SAS programmers with an average of 15 to 20 years of industry expertise embedded within your organisation. Our FSP professionals integrate seamlessly with your in-house operations, providing continuity and deep domain knowledge.
- Named resources with 15-20 years average experience
- Embedded within your team and processes
- Long-term continuity and institutional knowledge
- Flexible scaling to match pipeline demands
- KPI-driven governance and performance reviews
Hybrid Model
A tailored combination of full-service delivery and embedded FSP resources, designed to provide the right balance of project ownership and team augmentation based on your specific programme requirements and organisational structure.
- Customised blend of full-service and FSP
- Core team embedded, overflow project-based
- Seamless transition between engagement modes
- Optimised cost and resource efficiency
- Single governance framework across models
Industry Standards & Programming Tools
Our programming environment is built on industry-standard tools and validated processes, ensuring every deliverable meets the highest quality and compliance requirements demanded by global regulatory authorities.
CDISC Standards
Full support for SDTM, ADaM, CDASH, controlled terminology, and define.xml across all implementation guide versions.
SAS Platform
SAS 9.4, SAS Viya, SAS Enterprise Guide, and SAS Studio for flexible development environments across on-premise and cloud.
Pinnacle 21
Pinnacle 21 Community and Enterprise for comprehensive CDISC validation, compliance checking, and issue resolution prior to submission.
R Programming
R and RStudio for advanced statistical analysis, data visualisation, and emerging regulatory submission workflows alongside SAS.
Define.xml Tools
Specialised toolsets for define.xml 2.0 generation, metadata repository management, and controlled terminology mapping.
Validated Environment
21 CFR Part 11 compliant, GAMP 5 validated programming environment with full audit trail, version control, and access management.
Why Choose MTK for SAS Programming
Partnering with MTK means working with a team that combines deep regulatory expertise, proven programming methodologies, and a relentless focus on quality to deliver submission-ready outputs on time and to the highest standard.
Senior Expertise
Every programme is led by senior SAS programmers with 15 to 20 years of direct clinical trial experience across oncology, CNS, cardiovascular, immunology, and rare diseases, ensuring deep therapeutic and regulatory domain knowledge.
Regulatory Track Record
Proven track record of successful regulatory submissions to the FDA, EMA, PMDA, and other global authorities. Our programming deliverables have supported NDA, BLA, MAA, and IND filings across multiple therapeutic areas.
Quality First
Rigorous quality framework with double programming, independent QC, automated validation, and comprehensive documentation at every stage. Zero-defect delivery is our standard, not an aspiration.
Scalable & Flexible
Rapidly scalable programming teams that adapt to your pipeline demands. Whether you need a single study programmed or a full programme-level FSP engagement, we have the capacity and expertise to deliver.
Discuss Your Programming Needs
Contact our SAS programming team to discuss how our CDISC-compliant programming services, experienced statisticians, and flexible delivery models can support your clinical development programme from study setup through regulatory submission.