Biostatistics workspace with clinical analytics dashboards and study documents

Biostatistics for evidence leaders

PrecisionStats Counsulting

A senior biostats partner for clinical trials, regulatory submissions, real-world evidence, and publication-ready statistical storytelling.

68

studies supported

14

submission packages

99%

TLF QC pass rate

6

therapeutic areas

Services

Senior biostatistics muscle without the handoff drag.

The firm partners with biotech, medtech, and research teams that need statistical clarity, inspection-ready discipline, and calm execution under deadlines.

Trial design

Endpoints, estimands, randomization, sample size, interim rules, and protocol-aligned decision frameworks.

Signal

Adaptive methods

Signal

SAP ready

Signal

DMC support

Working style

Statistical judgement that holds up in the room.

Every engagement is led by a principal statistician and backed by reproducible programming, documented assumptions, and decision-grade communication.

01

Design before output

Questions, endpoints, estimands, and audience needs get aligned before tables multiply.

02

Traceable by default

Methods, code, quality checks, and decisions are built for audit trails and reviewer confidence.

03

Clear under pressure

Teams get crisp tradeoffs, defensible options, and plain-language readouts when timelines tighten.

04

Built to transfer

Deliverables arrive with structure, documentation, and context your internal team can keep using.

Portfolio

Statistical delivery for high-stakes clinical and market-access work.

Clinical trials

Adaptive Phase II oncology trial

Bayesian interim monitoring, SAP authoring, data review dashboards, and DMC-ready reporting cadence.

22% fewer screened participants needed

HEOR

Real-world evidence in cardiometabolic care

Propensity-score methods, sensitivity analyses, cohort transparency, and reproducible evidence packets.

4 claims sources harmonized

Regulatory

FDA-facing integrated safety package

ISS/ISE specifications, reviewer guide support, traceable TLF production, and response-team analytics.

Zero major statistical deficiencies

Publications

Rare disease publication program

Endpoint strategy, missing-data narratives, figure production, and reviewer response support.

3 manuscripts accepted

Engagement model

Right-sized statistics support from protocol to publication.

PrecisionStats Counsulting builds small senior teams around your study design, data maturity, compliance obligations, and communication rhythm.

9

delivery weeks

12

core outputs

86

QA hours

Analysis complexity

Contact

Bring statistical clarity to the next decision point.

Share the protocol, evidence question, regulatory milestone, or publication target. PrecisionStats Counsulting will map the statistical path and the working team.