Oncology Biostatistics
Oncology Biostatistics
COMPLEX INNOVATIVE TRIAL DESIGNS FOR CANCER DRUG DEVELOPMENT
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Bayesian adaptive designs, model based dose escalation, and seamless Phase I/II trials that satisfy FDA and EMA oncology requirements. Senior biostatisticians designing trials that answer regulatory questions the first time.
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The FDA Oncology Center of Excellence and Project Optimus have fundamentally changed how cancer drugs are evaluated. Traditional maximum tolerated dose approaches and rule based 3+3 designs are no longer sufficient for targeted therapies, antibody drug conjugates, and cell therapies.
Modern oncology trials require model based dose optimization, adaptive randomization, biomarker driven patient selection, and sophisticated safety monitoring frameworks. Your CRO can execute a protocol, but designing one that survives regulatory scrutiny requires deep oncology biostatistics expertise.
We architect clinical trials for cancer therapeutics using the complex innovative designs that regulators now expect. BOIN and mTPI for dose finding. Seamless Phase I/II designs that accelerate timelines. Master protocols for precision oncology. Statistical frameworks built specifically for the biology of your asset.
What We Offer
Bayesian Adaptive Dose Escalation
BOIN, mTPI, CRM, and BLRM designs for Phase I oncology trials. Model based dose optimization that finds the right dose faster with fewer patients than traditional 3+3 approaches. Designs that satisfy Project Optimus requirements for solid tumors, hematologic malignancies, and novel modalities including ADCs and radiopharmaceuticals.
Seamless Phase I/II Trial Design
Integrated dose finding and expansion cohort designs that accelerate your development timeline. Adaptive randomization, biomarker stratification, and interim analyses that let you make decisions without compromising statistical integrity. Designs optimized for immuno oncology combinations and targeted therapies.
Master Protocol Architecture
Basket, umbrella, and platform trial designs for precision oncology programs. Statistical frameworks that control type I error across multiple biomarker defined cohorts while allowing treatments to enter and exit the study. Operating characteristic simulations that demonstrate your design works before you enroll the first patient.
Statistical Analysis Plans
Comprehensive SAPs for Phase I through Phase III oncology trials. Primary and secondary endpoint specifications, multiplicity adjustments, estimand frameworks aligned with ICH E9(R1), sensitivity analyses, and subgroup analysis strategies. Documentation that supports your regulatory submission package.
IDMC Statistician Services
Independent Data Monitoring Committee statistical support for oncology trials. Unblinded interim analyses, safety signal detection, futility and efficacy boundaries, and closed session reporting. We serve as your independent statistician providing objective guidance to the committee throughout your trial.
Survival Analysis and Time to Event Endpoints
Kaplan Meier estimation, Cox proportional hazards modeling, restricted mean survival time analysis, and competing risks frameworks for oncology endpoints. Methods for non proportional hazards common in immuno oncology trials. Landmark analyses and conditional survival estimation for mature data.
How We Work
Discovery Call
A 30 minute conversation to understand your asset, development stage, and regulatory strategy. We discuss your trial design challenges and determine if our expertise matches your needs.
Design Development
We develop your trial design with operating characteristic simulations, sample size calculations, and statistical framework documentation. You receive a complete design package ready for protocol development.
Regulatory Alignment
We support FDA pre-IND and EMA scientific advice meetings, prepare statistical sections for briefing documents, and help you defend your design choices to regulators.
Ongoing Partnership
From SAP development through database lock, we remain available for interim analyses, protocol amendments, and regulatory questions. Fractional support that scales with your program needs.
Design Your Next Oncology Trial
Talk with a senior biostatistician about your Phase I/II design challenges. We will discuss your asset, your regulatory strategy, and how complex innovative designs can accelerate your program.
Your cancer trial data deserves more than a generalist.
Whether you need a statistical analysis plan for your Phase II solid tumor study or a network meta analysis for your NICE submission, let's talk.
Your cancer trial data deserves more than a generalist.
Whether you need a statistical analysis plan for your Phase II solid tumor study or a network meta analysis for your NICE submission, let's talk.
Your cancer trial data deserves more than a generalist.
Whether you need a statistical analysis plan for your Phase II solid tumor study or a network meta analysis for your NICE submission, let's talk.