Early stage oncology biotechs face a fundamental resource challenge. You need senior statistical leadership to design trials, interface with regulators, and oversee CRO execution. But a full time VP of Biostatistics commands a compensation package that consumes runway you cannot spare.

Large CROs offer functional service provider models, but they assign junior statisticians to smaller accounts. The person designing your trial is often learning on your data. When you need strategic guidance for an FDA meeting, you get templated responses rather than oncology specific insight.

Fractional biometrics solves this mismatch. You get direct access to a senior oncology biostatistician who joins your team part time. Someone who understands cancer drug development deeply enough to anticipate regulatory questions, challenge your CRO when their work falls short, and represent your statistical strategy to investors and advisory boards.

What We Offer

Fractional Head of Biostatistics

Part time statistical leadership scaled to your program stage. Monthly retainer engagements that provide strategic oversight, CRO management, and regulatory preparation. The expertise of a VP Biostatistics without the full time compensation burden.

FDA and EMA Meeting Representation

We prepare statistical sections for Type A, B, and C meeting briefing documents and attend meetings as your biostatistics representative. Pre-IND, end of Phase I, end of Phase II, and pre-NDA meeting support with oncology regulatory experience.

CRO Selection and Oversight

Vendor evaluation for biometrics service providers, RFP development, and bid defense support. Ongoing CRO oversight ensuring statistical deliverables meet your quality standards. We identify problems before they delay your program.

Data Monitoring Committee Support

IDMC charter development, statistical analysis plan alignment, and interim analysis coordination. We serve as your interface with the independent monitoring committee, ensuring smooth operations throughout your trial.

Investor and Board Presentations

Statistical narratives for investor presentations, board meetings, and advisory board discussions. We translate complex trial designs and interim results into clear communications that support your financing and governance needs.

Clinical Development Strategy

Biostatistics input on clinical development plans, regulatory pathways, and program prioritization. We help you sequence trials, select endpoints, and design studies that generate the evidence regulators and payers require.

How We Work

1. Program Assessment

We review your pipeline, current trial designs, CRO relationships, and regulatory history. This assessment identifies immediate needs and informs our engagement scope.

2. Retainer Structure

Monthly engagements scaled to your program stage. Early programs may need 20 hours monthly. Programs approaching pivotal trials may require more intensive support. Scope adjusts as your needs evolve.

3. Team Integration

We join your clinical development meetings, participate in CRO calls, and maintain ongoing communication with your team. Fractional means part time availability, not disconnected consulting.

4. Strategic Continuity

Unlike project based consulting, fractional engagements provide continuity across your development program. We understand your asset deeply and anticipate needs before they become urgent.