Executive Biometrics Consulting
Zenara provides senior-level biostatistical leadership to biotechnology and pharmaceutical companies navigating complex clinical development decisions. Founded and led by a former Head of Biostatistics with over 15 years of industry experience, Zenara partners with sponsors from first-in-human studies through late-phase development and regulatory submission.
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Our consulting model goes beyond execution. We integrate statistical science, clinical insight, and quantitative decision-making to help teams design better trials, interpret data with confidence, and accelerate development timelines—without sacrificing scientific rigor or regulatory credibility.
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With deep expertise across rare disease, oncology, immunology, neuroscience, hematology, and autoimmune indications, Zenara supports programs where uncertainty is high, data are limited, and strategic clarity is essential. Clients work directly with an experienced PhD-level biostatistician who has led INDs, NDAs, and global regulatory interactions at top-tier pharmaceutical companies.
Consulting Services
Our Features
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Who We Support
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Early-stage biotech (Seed → Series C)
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Lean teams need senior biometrics leadership
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How Zenara Is Different
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Senior-Level Only​
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​You work directly with an experienced former Head of Biostatistics — not a junior team.
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Decision-Focused Statistics
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​We focus on decisions, not just outputs: dose, design, risk, and regulatory strategy.
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Flexible Engagement Model
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Fractional leadership, project-based consulting, or strategic advisory — scaled to your needs.
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Engagement Models
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Fractional Head of Biometrics
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Strategic Advisory & Study Design
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Project-Based Statistical Consulting
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Regulatory Submission Support
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Therapeutic & Technical Expertise
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Therapeutic
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Rare disease, oncology, immunology, neuroscience, hematology, autoimmune
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Techinical
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Bayesian methods, adaptive designs, PK/PD, biomarkers, CDISC, regulatory submissions
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Early Phase Biomarker and PK/PD Data Strategy
We specialize in early clinical development where biomarker, PK/PD, and dose-selection decisions define program success. Zenara supports first-in-human, SAD/MAD, DDI, renal/hepatic impairment, and proof-of-concept studies across small and large molecules.
Our approach integrates PK/PD modeling, exposure-response analysis, Bayesian methods, and mechanism-linked biomarkers (including flow cytometry and cytokines) to create decision-ready insights. We help sponsors translate nonclinical and early clinical data into clear dose rationale, cohort expansion strategies, and go/no-go decisions
Innovative Trial Design and Virtual Trial Simulations
Zenara designs innovative and adaptive clinical trials tailored to each program’s scientific and operational constraints. We apply Bayesian adaptive designs, dose-escalation models (e.g., BOIN), synthetic controls, and simulation-based trial optimization to improve efficiency and reduce development risk.
Virtual trial simulations are used to evaluate design options, sample size, operating characteristics, and decision thresholds—supporting smarter protocol choices before patients are enrolled. This service is particularly valuable for rare disease, oncology, and complex early-phase programs.
Data Package for Regulatory Submission
We provide end-to-end statistical support for regulatory submissions, including INDs, NDAs, BLAs, and MAAs. Zenara leads statistical strategy, prepares and reviews SAPs, TFLs, and CSR statistical sections, and supports regulatory interactions and responses.
Our experience includes multiple FDA submissions across diverse therapeutic areas, with a strong focus on scientific rigor, transparency, and defensible analyses. We also conduct gap assessments and risk reviews to ensure submission readiness and alignment with regulatory expectations.
AI Application for Biometrics
Zenara develops modern, user-friendly analytics solutions that transform how clinical data are reviewed and communicated. We build custom R Shiny applications and AI-enabled workflows for real-time visualization of safety, efficacy, PK, and biomarker data.
These tools streamline analysis, improve cross-functional decision-making, and dramatically reduce turnaround time for traditional TFLs and reports. AI-assisted solutions can also support automation of reporting and medical writing, helping teams move faster while maintaining quality and compliance.