Biostatistical Consulting

What Biostatistical Consulting does

Biostatistical Consulting Inc. (BCI) is a privately held, Lexington, Massachusetts-based professional services firm founded in 2007 by Eugene Poggio, PhD. The firm provides biostatistical and statistical programming services to the biotechnology, pharmaceutical, and medical device industries in support of clinical trials spanning Phases 1 through 4. BCI positions itself as a "select team" of senior biostatisticians and statistical programmers (stated headcount band: 1–10) offering full-lifecycle support from study design strategy and sample size calculations through statistical analysis plan development, interim and final analyses, tables/listings/graphs production, and regulatory submissions for IND, NDA, BLA, IDE, PMA, and 510(k) pathways. The firm also supports data monitoring committee participation and represents clients before the FDA and regulatory authorities in Europe, Japan, and Canada.

BCI's core technology is deep methodological expertise in biostatistics applied to clinical development, with codified CDISC ADaM compliance capability, classical and adaptive trial design competence, and senior biostatistician-led delivery. The leadership bench includes a Director of Biostatistics (Roger Johnson, PhD, Applied Statistics) with ~30 years of sponsor and CRO experience, and an Associate Director (Rong Lin, MD, MPH, Yale) who specializes in CDISC standards and ADaM.

BCI operates a B2B, sales-led, professional services revenue model. Services are delivered on what appears to be a time-and-materials or fixed-scope consulting basis (no pricing is publicly disclosed). Distribution is direct, with the founder and senior staff functioning as the primary client-relationship channel. The firm advertises a quality, timeliness, and communication orientation as its differentiators versus larger CROs, and cites positive unsolicited client feedback as its primary marketing asset. No funding rounds, acquisitions, partnerships, or product lines outside the core statistical services offering are disclosed.

Name

Biostatistical Consulting

Legal name

Biostatistical Consulting, Inc.

Website

https://biostatisticalconsulting.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

1–10 employees

Short description

Biostatistical Consulting Inc. (BCI) is a Lexington, MA-based professional services firm providing biostatistical and statistical programming support for clinical trials to pharmaceutical, biotechnology, and medical device sponsors, from study design through regulatory submissions.

Ownership category

akta.pro rank

Product category

Biostatistical consulting services

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Management Consulting Services (8742)

akta.pro primary industry

Biostatistics, Statistical Computing & Clinical Programming (SAS/R/Pipelines) (HLACAOAO)

akta.pro secondary industry

Data Management, Biostatistics & Statistical Programming FSP (HLAGAOAB)

Keywords

• Biostatistics consulting
• Clinical trial design
• Statistical programming
• Regulatory submissions support
• Adaptive trial design

Headquarters

HQ city

Lexington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations

Revenue model

1. Biostatistics Consulting Services: Professional consulting services provided to pharmaceutical, biotechnology, and medical device industries for clinical trial design and analysis. Services include strategic statistical consulting, study design, statistical analysis, and regulatory submission support.

Go-to-market motion1 record

Distribution channels1 record

Core offering

Biostatistical Consulting Inc. delivers biostatistics and statistical programming services for clinical trials across the biotechnology, pharmaceutical, and medical device industries. The firm's work spans the full clinical trial lifecycle from study-design strategy and statistical analysis plan development through interim/final analyses, tables/listings/graphs, data monitoring committee support, and regulatory submissions (IND, NDA, BLA, IDE, PMA, 510(k)). Services also include direct statistical representation at FDA and European, Japanese, and Canadian regulatory agencies.

Product overview

Biostatistical Consulting Inc. (BCI) is a services company providing expert biostatistical and statistical programming services as a single, unified offering. The core service encompasses strategic statistical consulting, clinical trial design (classical and adaptive designs), statistical analysis and reporting, data monitoring committee support, regulatory representation, and regulatory submission support for IND, NDA, BLA, IDE, PMA, and 510(k) applications. Services are delivered by a team of biostatisticians and statistical programmers with expertise spanning all phases of clinical trials and therapeutic areas.

Differentiator

Problem solved

Functional benefit

Products and services

• Strategic Statistical Consulting High-level statistical strategy and consulting provided to pharmaceutical, biotechnology, and medical device sponsors across the clinical trial lifecycle, focused on the design and analysis of clinical trials and supported by experience in epidemiology studies and patient registries.
• Study Design Services Clinical trial study design services including classical and adaptive designs, sample size and power calculations, writing statistical sections of protocols, CRF review, randomization, and statistical analysis plan (SAP) development for pharmaceutical, biotechnology, and medical device sponsors.
• Statistical Analyses and Reporting Statistical analysis and reporting services for clinical trials, including interim analyses, final analyses, production of tables, listings and graphs, writing statistical sections of Clinical Study Reports, and integrated summaries of efficacy and safety for pharmaceutical, biotechnology, and medical device sponsors.
• Data Monitoring Committee Support Participation as statistician on Data Monitoring Committees (DMCs) and dedicated statistical support for DMCs across clinical trial programs, serving pharmaceutical, biotechnology, and medical device sponsors.
• Statistical Representation with Regulatory Authorities Direct representation of clients in statistical matters before regulatory authorities including FDA, and European and Japanese regulatory authorities, drawing on BCI's senior biostatisticians' regulatory experience.
• Statistical Support for Regulatory Submissions Statistical support for regulatory submissions across IND, NDA, and BLA pathways (drugs and biologics) and across IDE, PMA, and 510(k) pathways (medical devices), provided to pharmaceutical, biotechnology, and medical device sponsors.

Quantifiable outcome

• Clients consistently commend quality and timeliness of work as well as ability to communicate statistical matters clearly

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Scale indicators2 records

Recent moves4 records

Expansion highlights4 records

Direct peers

• Phastar: A specialist biostatistics, data science, and statistical programming CRO serving pharma, biotech, and medical device sponsors — competes head-to-head with BCI on biostatistics consulting and CDISC/ADaM deliverables.
• Berry Consultants: A specialty biostatistics consultancy renowned for adaptive clinical trial design and simulation-based methodologies — closely comparable to BCI's classical and adaptive design offerings and serves the same pharma/biotech sponsor base.
• Veristat: A biostatistics-focused CRO providing statistical programming, data management, CDISC services, and regulatory submission support to pharma/biotech — directly comparable to BCI's core service mix with a similar mid-tier positioning.
• MMS Holdings: A clinical research and data services firm providing biostatistics, statistical programming, and regulatory submission support to pharma/biotech — directly comparable to BCI on biostatistics, CDISC, and regulatory representation services.
• Statistics Collaborative, Inc. A Washington, D.C.-based boutique biostatistical consulting firm focused exclusively on statistical analysis, study design, and regulatory submission support for pharmaceutical and biotech clients — directly analogous to BCI in size, service scope, and customer base.
• Cytel: A leading biostatistics and advanced analytics CRO providing study design, programming, and CDISC-compliant data services to pharma/biotech — overlaps directly with BCI on biostatistics, statistical programming, and ADaM expertise but operates at meaningfully larger scale.
• Rho: A full-service CRO with strong biostatistics, data management, and regulatory capabilities for pharma/biotech/medical device sponsors — overlaps with BCI's biostatistics and regulatory submission support but with broader clinical operations scope.

Broad incumbents

• Medpace: A large, therapeutically focused CRO with embedded biostatistics and statistical programming functions across all trial phases — offers all of BCI's services as part of a full-service clinical operations portfolio.
• IQVIA: The world's largest CRO/biopharmaceutical services company with extensive biostatistics, statistical programming, and regulatory capabilities — overlaps with BCI as a broad incumbent dominating the biostatistics services market.
• Parexel International: A major global CRO providing biostatistics, statistical programming, regulatory consulting, and full clinical development services — comparable as a broad incumbent across the same regulatory submission and biostatistics workflow BCI serves.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/biostatistical-consulting-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Biostatistical Consulting