VOICES

Explore our FDA-focused solution areas to see how we support medical device and pharmaceutical companies across regulatory pathways and product types, from early strategy through approval-ready submissions.

VOICES

Explore our FDA-focused solution areas to see how we support medical device and pharmaceutical companies across regulatory pathways and product types, from early strategy through approval-ready submissions.

Do Work That

Stands Up to Scrutiny.

Do Work That

Stands Up to Scrutiny.

Do Work That

Stands Up to Scrutiny.

Do Work That

Stands Up to Scrutiny.

Biomedical Statistical Consulting® (BSC®) is a specialized biostatistics and regulatory consulting firm supporting life-science companies from early study design through FDA submission. We work with teams developing medical devices, diagnostics, and therapeutics in highly regulated environments, providing statistical rigor and regulatory clarity where scrutiny is high and decisions matter. BSC® combines deep biostatistical expertise with hands-on FDA experience. Engagements are led by senior experts who work directly with clients to reduce risk, strengthen submissions, and support successful regulatory outcomes.
Biomedical Statistical Consulting® (BSC®) is a specialized biostatistics and regulatory consulting firm supporting life-science companies from early study design through FDA submission. We work with teams developing medical devices, diagnostics, and therapeutics in highly regulated environments, providing statistical rigor and regulatory clarity where scrutiny is high and decisions matter. BSC® combines deep biostatistical expertise with hands-on FDA experience. Engagements are led by senior experts who work directly with clients to reduce risk, strengthen submissions, and support successful regulatory outcomes.
Biomedical Statistical Consulting® (BSC®) is a specialized biostatistics and regulatory consulting firm supporting life-science companies from early study design through FDA submission. We work with teams developing medical devices, diagnostics, and therapeutics in highly regulated environments, providing statistical rigor and regulatory clarity where scrutiny is high and decisions matter. BSC® combines deep biostatistical expertise with hands-on FDA experience. Engagements are led by senior experts who work directly with clients to reduce risk, strengthen submissions, and support successful regulatory outcomes.

Join us

in advancing the science

of better clinical decisions.

Build with a team of biostatisticians, data scientists, and regulatory experts supporting life-changing therapies from study design to submission.

Science First

Science First

Science First.

Science First.

People Always.

People Always.

At BSC, you’ll work on projects that directly shape regulatory decisions and patient outcomes. Our consultants contribute to high-impact clinical programs while maintaining the independence, precision, and integrity that scientific work demands.

At BSC, you’ll work on projects that directly shape regulatory decisions and patient outcomes. Our consultants contribute to high-impact clinical programs while maintaining the independence, precision, and integrity that scientific work demands.

We value deep expertise, thoughtful collaboration, and clear communication — internally and with our clients.

We value deep expertise, thoughtful collaboration, and clear communication — internally and with our clients.

Expert-Led.

Expert-Led.

Collaborative by Design.

Collaborative by Design.

You’ll join a team of statisticians and scientific advisors who take ownership of their work and support one another through complex challenges.

You’ll join a team of statisticians and scientific advisors who take ownership of their work and support one another through complex challenges.

We work closely with sponsors, clinicians, and regulators, which means your contributions are visible, valued, and consequential — not buried in layers of process.

We work closely with sponsors, clinicians, and regulators, which means your contributions are visible, valued, and consequential — not buried in layers of process.

Expert Led

Expert Led

Continuous Excellence

Continuous Excellence

Continuous Excellence

Continuous Excellence

Relentless Effort

Relentless Effort

While other CROs shy away from difficult projects, we embrace them. Rescue trials, regulatory appeals, breakthrough device submissions, adaptive designs under FDA scrutiny—these aren't problems we avoid, they're the puzzles that energize us.

While other CROs shy away from difficult projects, we embrace them. Rescue trials, regulatory appeals, breakthrough device submissions, adaptive designs under FDA scrutiny—these aren't problems we avoid, they're the puzzles that energize us.

We're grounded in scientific integrity and unwavering client advocacy. We address hard truths, make difficult recommendations, and make the best reccomendations for our clients.

We're grounded in scientific integrity and unwavering client advocacy. We address hard truths, make difficult recommendations, and make the best reccomendations for our clients.

Values

Powering the Future

Powering the Future

with Principles That Guide Every Decision.

with Principles That Guide Every Decision.

Our multidisciplinary team combines senior biostatisticians, data scientists, and regulatory experts to support complex clinical programs—from early development through approval.

Mission-Critical Momentum

We operate in an environment where delays aren't just inconveniences—they are lost opportunities for life-changing innovation. We meet high-stakes deadlines with a "finish line" mentality, prioritizing decisive action and scientific rigor. Because our clients depend on us during their most critical windows, we maintain a culture of high responsiveness and radical accountability. Here, reliability isn't just a goal; it's our standard of excellence.

Mission-Critical Momentum

We operate in an environment where delays aren't just inconveniences—they are lost opportunities for life-changing innovation. We meet high-stakes deadlines with a "finish line" mentality, prioritizing decisive action and scientific rigor. Because our clients depend on us during their most critical windows, we maintain a culture of high responsiveness and radical accountability. Here, reliability isn't just a goal; it's our standard of excellence.

Continuous Excellence

The statistical and regulatory landscape evolves constantly, and so do we. We are committed to professional development at every level, ensuring our team is always equipped for the next challenge. Our culture is built on staying ahead of emerging methods and growing alongside the most recognized experts in the field. Here, you’ll be part of an organization that never stops getting better.

Continuous Excellence

The statistical and regulatory landscape evolves constantly, and so do we. We are committed to professional development at every level, ensuring our team is always equipped for the next challenge. Our culture is built on staying ahead of emerging methods and growing alongside the most recognized experts in the field. Here, you’ll be part of an organization that never stops getting better.

Forward-Thinking Problem Solvers

We don't wait for problems to find us—we anticipate what's coming. Understanding your challenge is 80% of the game, and we're adept at asking the right questions to get to the right answer. Whether it's a novel technology without regulatory precedent or a dataset that defies standard analysis, we find a way. You'll have the freedom to think creatively and the support to deliver solutions no one else could.

Forward-Thinking Problem Solvers

We don't wait for problems to find us—we anticipate what's coming. Understanding your challenge is 80% of the game, and we're adept at asking the right questions to get to the right answer. Whether it's a novel technology without regulatory precedent or a dataset that defies standard analysis, we find a way. You'll have the freedom to think creatively and the support to deliver solutions no one else could.

Collaborative by Design

Understanding your problem is 80% of the game—and that's what we do exceptionally well. We listen carefully, ask the right questions, and leverage the information you already have instead of starting from scratch with templates. Our clients never have to explain themselves twice. You'll learn to build trust through deep understanding, not just deliverables.

Collaborative by Design

Understanding your problem is 80% of the game—and that's what we do exceptionally well. We listen carefully, ask the right questions, and leverage the information you already have instead of starting from scratch with templates. Our clients never have to explain themselves twice. You'll learn to build trust through deep understanding, not just deliverables.

Global Reach,

Proven Scientific Impact.

From early-phase studies to regulatory submissions, these metrics reflect the scale, rigor, and reliability of our biostatistical work.

1986

1986

Year founded

Year founded

800+

800+

Projects supported

Projects supported

500+

500+

Clinical studies supported

Clinical studies supported

100%

100%

Signficant value added

Signficant value added

Benefits

Our benefits and why we

Our benefits and why we

invest in our people.

invest in our people.

Reward & Recognition

Competitive salary

Competitive salary

Competitive salary

Annual performance bonuses

Referral bonus

Flexibility at work

Flexible hours

Work from Philadelphia USA or anywhere in the world

Flexible PTO

Health & Wellbeing

Comprehensive health, dental, and vision coverage

Access to world class gym

Retirement plan with company match

Learning & Growth

Annual learning stipend

Training and conferences

Career development opportunities

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.