BSC® Solutions
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.
BSC® Solutions
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.
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Senior Biostatistician
Lead complex regulatory submissions that set new standards for excellence.
Location
Philadelphia and Remote
Your Mission
Lead complex regulatory submissions that set new standards for excellence. Work directly with senior leadership on high-impact programs across medical devices and pharmaceuticals. Contribute to methodological innovation while ensuring FDA-compliant, submission-grade outputs. Ideal candidates hold a Master’s or PhD and bring 5+ years of industry experience with advanced statistical methods.
About the Role
You’ll work on high-impact clinical and regulatory programs where statistical decisions directly influence FDA outcomes. This role sits at the intersection of biostatistics, clinical development, and regulatory strategy, with responsibility for shaping analyses that must withstand real regulatory scrutiny.
You’ll contribute to study design, statistical analysis plans, regulatory submissions, and FDA interactions across medical device and life-science programs. Projects range from early feasibility through pivotal trials and post-submission support, often involving non-standard designs, external controls, or complex evidentiary challenges.
You’ll work on high-impact clinical and regulatory programs where statistical decisions directly influence FDA outcomes.
This role sits at the intersection of biostatistics, clinical development, and regulatory strategy, with responsibility for shaping analyses that must withstand real regulatory scrutiny.
What You’ll Work On
You’ll work on high-impact clinical and regulatory programs where statistical decisions directly influence FDA outcomes. This role sits at the intersection of biostatistics, clinical development, and regulatory strategy, with responsibility for shaping analyses that must withstand real regulatory scrutiny.
You’ll contribute to study design, statistical analysis plans, regulatory submissions, and FDA interactions across medical device and life-science programs. Projects range from early feasibility through pivotal trials and post-submission support, often involving non-standard designs, external controls, or complex evidentiary challenges.
You’ll work on high-impact clinical and regulatory programs where statistical decisions directly influence FDA outcomes.
This role sits at the intersection of biostatistics, clinical development, and regulatory strategy, with responsibility for shaping analyses that must withstand real regulatory scrutiny.
How We Work
You’ll work on high-impact clinical and regulatory programs where statistical decisions directly influence FDA outcomes. This role sits at the intersection of biostatistics, clinical development, and regulatory strategy, with responsibility for shaping analyses that must withstand real regulatory scrutiny.
You’ll contribute to study design, statistical analysis plans, regulatory submissions, and FDA interactions across medical device and life-science programs. Projects range from early feasibility through pivotal trials and post-submission support, often involving non-standard designs, external controls, or complex evidentiary challenges.
You’ll work on high-impact clinical and regulatory programs where statistical decisions directly influence FDA outcomes.
This role sits at the intersection of biostatistics, clinical development, and regulatory strategy, with responsibility for shaping analyses that must withstand real regulatory scrutiny.
What We Look For
You’ll work on high-impact clinical and regulatory programs where statistical decisions directly influence FDA outcomes. This role sits at the intersection of biostatistics, clinical development, and regulatory strategy, with responsibility for shaping analyses that must withstand real regulatory scrutiny.
You’ll contribute to study design, statistical analysis plans, regulatory submissions, and FDA interactions across medical device and life-science programs. Projects range from early feasibility through pivotal trials and post-submission support, often involving non-standard designs, external controls, or complex evidentiary challenges.
You’ll work on high-impact clinical and regulatory programs where statistical decisions directly influence FDA outcomes.
This role sits at the intersection of biostatistics, clinical development, and regulatory strategy, with responsibility for shaping analyses that must withstand real regulatory scrutiny.
Why BSC®
You’ll work on high-impact clinical and regulatory programs where statistical decisions directly influence FDA outcomes. This role sits at the intersection of biostatistics, clinical development, and regulatory strategy, with responsibility for shaping analyses that must withstand real regulatory scrutiny.
You’ll contribute to study design, statistical analysis plans, regulatory submissions, and FDA interactions across medical device and life-science programs. Projects range from early feasibility through pivotal trials and post-submission support, often involving non-standard designs, external controls, or complex evidentiary challenges.
You’ll work on high-impact clinical and regulatory programs where statistical decisions directly influence FDA outcomes.
This role sits at the intersection of biostatistics, clinical development, and regulatory strategy, with responsibility for shaping analyses that must withstand real regulatory scrutiny.
Testimonials
See what our sponsors say about BSC
On Experience
Battle ground tested. There is nothing that David and team haven't seen over the years – good bad and ugly.
• VP, Clinical Operations
• CEO, Medical Device Company
• Former FDA Regulator
Questions answered
Any other question?
Contact us
Let's help you find a path
to market
About BSC®
Working With BSC®
Services
Project logistics
Data and Software
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Questions answered
Any other question?
Contact us
Let's help you find a path
to market
About BSC®
Working With BSC®
Services
Project logistics
Data and Software
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Questions answered
Any other question?
Contact us
Let's help you find a path
to market
About BSC®
Working With BSC®
Services
Project logistics
Data and Software
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Questions answered
Any other question?
Contact us
Let's help you find a path
to market
About BSC®
Working With BSC®
Services
Project logistics
Data and Software
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Featured Resources
Get regulatory insights
from BSC®
Explore more
Featured Resources
Get regulatory insights
from BSC®
Explore more
Featured Resources
Get regulatory insights
from BSC®
Explore more
Featured Resources
Get regulatory insights
from BSC®
Explore more
Security
Robust data security and confidentiality
across sensitive, FDA-regulated clinical and regulatory data.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
GDPR
SOC2 - in progress
Security
Robust data security and confidentiality
across sensitive, FDA-regulated clinical and regulatory data.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
GDPR
SOC2 - in progress
Security
Robust data security and confidentiality
across sensitive, FDA-regulated clinical and regulatory data.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
GDPR
SOC2 - in progress
Security
Robust data security and confidentiality
across sensitive, FDA-regulated clinical and regulatory data.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
GDPR
SOC2 - in progress
Partner with us
Partner with us
Partner with us
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.
Use your preferred LLM to explore BSC®
Use your preferred LLM to explore BSC®