Biostatistics & Statistical Consulting
Rigorous statistical design, analysis, and reporting that form the scientific backbone of your clinical development programme. Our biostatisticians bring deep methodological expertise and regulatory insight to every phase of your trial -- from first-in-human through post-marketing commitments.
Rigorous Statistical Design & Analysis
MTK Pharma Services delivers end-to-end biostatistics support underpinned by scientific rigour, regulatory awareness, and a commitment to data-driven decision-making. Our statisticians partner with sponsors, medical teams, and programmers from the earliest stages of protocol development to ensure that every study is designed to answer the right questions with the appropriate statistical power.
With an average of 15 to 20 years of industry expertise, our biostatistics professionals bring deep therapeutic knowledge and hands-on experience across Phase I through Phase IV trials. Whether you need a single SAP consultation or a fully embedded statistical team, MTK provides the methodological foundation that regulators and stakeholders demand.
Comprehensive Biostatistics Services
Eight key areas of statistical expertise that support every stage of your clinical development programme -- from study design and planning through regulatory submission and post-marketing analysis.
Study Design & Protocol Support
Robust study designs built on sound statistical principles to maximise the probability of meeting your development objectives.
- Sample size and power calculations
- Randomisation scheme design
- Adaptive design strategies
- Protocol statistical sections
Statistical Analysis Plans
Comprehensive SAP development that clearly defines every planned analysis, ensuring alignment between clinical objectives and statistical methodology.
- Comprehensive SAP development
- Analysis methodology specification
- Primary & secondary endpoint definitions
- Mock shell table design
Interim Analyses & DSMB Support
Independent statistical support for Data Safety Monitoring Boards with rigorous interim analysis planning and unblinded reporting.
- Interim analysis planning
- Stopping rules and boundaries
- DSMB charter development
- Unblinded interim reports
Primary & Secondary Analyses
Definitive hypothesis testing and efficacy evaluation with robust multiplicity control and pre-specified sensitivity analyses.
- Hypothesis testing frameworks
- Multiplicity adjustment methods
- Sensitivity and subgroup analyses
- Missing data handling strategies
Integrated Summary Reports
Cross-study statistical summaries that synthesise safety and efficacy evidence to build a compelling regulatory submission package.
- ISS and ISE development
- Pooled safety and efficacy analyses
- Meta-analyses across studies
- Benefit-risk assessment support
CSR Statistical Sections
Clear, regulatory-ready statistical methodology and results sections for Clinical Study Reports that withstand rigorous agency review.
- Statistical methodology sections
- Results interpretation and narrative
- Efficacy and safety conclusions
- Regulatory-ready documentation
Advanced Statistical Methods
Cutting-edge methodologies for complex trial designs and innovative analytical approaches that go beyond traditional frequentist methods.
- Bayesian statistical methods
- Survival and time-to-event analysis
- Longitudinal data modelling
- Machine learning applications
Regulatory Interactions
Expert statistical support for health authority interactions, ensuring your statistical strategy is clearly communicated and well-defended.
- FDA/EMA statistical briefing documents
- Responses to agency questions
- Advisory committee support
- Pre-submission meeting preparation
Flexible Delivery Models
Choose the engagement model that best fits your organisation's needs, from fully outsourced biostatistics to embedded functional service teams and everything in between.
Full-Service
End-to-end biostatistics ownership from study design through final CSR statistical sections. MTK takes full accountability for all statistical deliverables, timelines, and regulatory interactions on your behalf.
- Complete statistical programme management
- Dedicated lead biostatistician
- All deliverables from SAP to CSR
- Regulatory submission support
- Fixed-price or time-and-materials
Functional Service Provider (FSP)
Dedicated, embedded biostatisticians with 15 to 20 years of industry expertise who integrate seamlessly with your in-house teams, providing long-term continuity and deep institutional knowledge.
- Named, dedicated statisticians
- 15–20 years average experience
- Embedded in your processes and SOPs
- Scalable team size on demand
- KPI-driven governance model
Hybrid Model
A tailored combination of full-service project delivery and embedded FSP resources, giving you maximum flexibility to allocate statistical expertise precisely where your pipeline demands it most.
- Mix of project and embedded resources
- Flexible scope adjustments
- Shared governance framework
- Seamless cross-team collaboration
- Optimised cost efficiency
Therapeutic Area Expertise
Our biostatisticians bring deep therapeutic knowledge gained across hundreds of clinical programmes. This domain expertise enables us to anticipate design challenges, select optimal endpoints, and apply the most appropriate statistical methodologies for each indication.
Oncology
Survival analysis, tumour response endpoints, adaptive Phase I dose-escalation, basket and umbrella trial designs, and immuno-oncology endpoints.
CNS & Neuroscience
Longitudinal cognitive assessments, mixed-effects modelling, enrichment designs, and disease-modification endpoints in neurodegenerative indications.
Cardiovascular
MACE composite endpoint analyses, large outcome trials, cardiovascular safety assessments, and event-driven study designs.
Rare Disease
Small-sample statistical methods, natural history comparisons, Bayesian borrowing, and adaptive designs for limited patient populations.
Vaccines
Immunogenicity analyses, seroconversion rates, lot consistency studies, correlates of protection, and large-scale efficacy trial design.
Why Choose MTK for Biostatistics
Selecting the right biostatistics partner is a critical decision that directly impacts the scientific integrity, regulatory success, and timeline of your clinical programme. Here is what sets MTK apart.
Senior Expertise
Every engagement is led by a senior biostatistician with 15 to 20 years of hands-on clinical trial experience, ensuring sound methodology and credible regulatory interactions.
Global Regulatory Reach
Proven track record with FDA, EMA, MHRA, PMDA, and other major health authorities. We know what regulators expect and how to present your statistical story convincingly.
Integrated Delivery
Seamless collaboration with our SAS programming, data management, and medical writing teams delivers a unified workflow that eliminates hand-off delays and reduces errors.
Quality & Compliance
SOPs aligned to ICH-GCP, CDISC standards, and 21 CFR Part 11. Every deliverable undergoes independent QC review with full audit trail documentation.
Discuss Your Biostatistics Needs
Whether you need a single study SAP, a dedicated biostatistics team, or strategic statistical consulting for a complex regulatory interaction, our experts are ready to help. Contact us to explore how MTK can strengthen the statistical foundation of your clinical programme.