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Medical Device Biostatistician Jobs (NOW HIRING)

PPG US ProPharma Group, LLC

WI · On-site

$100 - $150/hr

... biotech, med device, and pharmaceutical organizations of all sizes to confidently advance ... Keep up to date with regulatory guidelines and industry standards related to biostatistics and ...

ProPharma Group

Senior Biostatistician

Charleston, WV · On-site

... biotech, med device, and pharmaceutical organizations of all sizes to confidently advance ... Keep up to date with regulatory guidelines and industry standards related to biostatistics and ...

Medpace, Inc.

Biostatistician I

Cincinnati, OH · On-site

D. degree in Biostatistics / Statistics with strong experience in SAS Programming or equivalent ... medical device industries. Our mission is to accelerate the global development of safe and ...

Medpace, Inc.

Biostatistician I

Cincinnati, OH · On-site +1

D. degree in Biostatistics / Statistics with strong experience in SAS Programming or equivalent ... medical device industries. Our mission is to accelerate the global development of safe and ...

MMS

Senior Biostatistician - Remote (US)

Chicago, IL · On-site

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Senior Biostatistician: Responsibilities: * Create randomization and kit schedules independently ...

MMS

Senior Biostatistician - Remote (US)

Miami, FL · On-site

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Senior Biostatistician: Responsibilities: * Create randomization and kit schedules independently ...

MMS

Senior Biostatistician - Remote (US)

Raleigh, NC · On-site

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Senior Biostatistician: Responsibilities: * Create randomization and kit schedules independently ...

MMS

Senior Biostatistician - Remote (US)

Toledo, OH · On-site

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Senior Biostatistician: Responsibilities: * Create randomization and kit schedules independently ...

MMS

Senior Biostatistician - Remote (US)

Canton, MI · On-site

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Senior Biostatistician: Responsibilities: * Create randomization and kit schedules independently ...

MMS

Senior Biostatistician - Remote (US)

Boston, MA · On-site

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Senior Biostatistician: Responsibilities: * Create randomization and kit schedules independently ...

MMS

Senior Biostatistician - Remote (US)

Austin, TX · On-site

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Senior Biostatistician: Responsibilities: * Create randomization and kit schedules independently ...

MMS

Senior Biostatistician - Remote (US)

Nashville, TN · On-site

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Senior Biostatistician: Responsibilities: * Create randomization and kit schedules independently ...

MMS

Senior Biostatistician - Remote (US)

Zionsville, IN · On-site

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Senior Biostatistician: Responsibilities: * Create randomization and kit schedules independently ...

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Medical Device Biostatistician information

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How much do medical device biostatistician jobs pay per hour?

As of Aug 22, 2026, the average hourly pay for medical device biostatistician in the United States is $57.55, according to ZipRecruiter salary data. Most workers in this role earn between $40.62 and $64.42 per hour, depending on experience, location, and employer.

What is a medical device biostatistician?

Medical Device Biostatisticians are professionals who apply statistical methods to the design, analysis, and interpretation of data generated from medical device studies. They play a crucial role in ensuring that medical devices are safe and effective by working closely with clinical researchers, regulatory teams, and engineers. Their expertise is essential during clinical trials, regulatory submissions, and post-market surveillance to meet regulatory standards and guide decision-making throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a medical device biostatistician?

To thrive as a Medical Device Biostatistician, you need a strong background in statistics, clinical trial design, and regulatory guidelines, typically supported by an advanced degree in statistics, biostatistics, or a related field. Proficiency in statistical software such as SAS, R, or Python, and familiarity with FDA or EMA submission standards are essential. Strong communication skills, attention to detail, and problem-solving abilities set outstanding candidates apart. These skills ensure accurate data analysis, regulatory compliance, and effective collaboration in the development and approval of medical devices.

How does a medical device biostatistician typically collaborate with regulatory teams during the product approval process?

Medical Device Biostatisticians play a crucial role in working alongside regulatory teams by designing and analyzing clinical studies that meet strict regulatory requirements. They ensure that statistical methodologies align with FDA or international guidelines and clearly communicate results to both scientific and regulatory stakeholders. This collaboration often involves preparing statistical sections for regulatory submissions, responding to agency queries, and participating in meetings to clarify data interpretations. Effective communication and attention to detail are essential, as the biostatistician's input directly impacts the device's approval timeline and success.

What is the difference between Medical Device Biostatistician vs Clinical Data Analyst?

AspectMedical Device Biostatistician
CredentialsMaster's or PhD in Biostatistics, Statistics, or related field
Work EnvironmentPharmaceutical/medical device companies, research organizations, clinical trial settings
Employer & IndustryMedical device manufacturers, biotech firms, clinical research organizations
Primary FocusDesigning and analyzing clinical trials for medical devices

While both roles involve data analysis in healthcare, a Medical Device Biostatistician specializes in designing and analyzing clinical trials specifically for medical devices, requiring advanced statistical expertise. A Clinical Data Analyst may work across various healthcare data sets but typically focuses on managing and interpreting clinical data without the specialized focus on trial design for medical devices.

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Medical Device Biostatistician jobs near you
Infographic showing various Medical Device Biostatistician job openings in the United States as of August 2026, with employment types broken down into 92% Full Time, 3% Part Time, and 5% Contract. Highlights an 69% In-person, 2% Hybrid, and 29% Remote job distribution, with an average salary of $119,702 per year, or $57.5 per hour.

Senior Biostatistician

PPG US ProPharma Group, LLC

WI • On-site

$100 - $150/hr

Other

Posted 5 days ago

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Essential Functions:
  • Lead statistical activities for clinical trials and data analyses, including study design, statistical analysis plan development, and statistical analysis.
  • Provide statistical expertise to cross functional teams, including clinical operations, data management, and regulatory affairs.
  • Ensure the quality and accuracy of statistical deliverables, including statistical reports, tables, listings, and graphs.
  • Participate in the development and review of clinical study protocols and case report forms (CRFs) to ensure appropriate statistical analysis.
  • Develop and maintain SAS programs for statistical analysis in accordance with standard operating procedures (SOPs), good programming practices, and regulatory guidelines.
  • Keep up to date with regulatory guidelines and industry standards related to biostatistics and ensure compliance with these guidelines.
  • Participate in the development and maintenance of internal processes and standard operating procedures to improve statistical efficiency and consistency.
  • Provide guidance and mentorship to junior statisticians.
  • Other duties as assigned.
Necessary Skills and Abilities:
  • In-depth knowledge of statistical methodologies.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners.
  • Strong project management skills, with the ability to manage multiple projects simultaneously.
  • Knowledge of regulatory requirements and guidelines related to statistical analysis and reporting of clinical trial data.
  • Ability to program in SAS and or R.
Educational Requirements:

Ph.D. in Biostatistics, or M.S. in Biostatistics.

Experience Requirements:
  • 3+ years of relevant work experience.
  • Outsourcing industry experience required.
  • Experience in clinical trial design, sample size calculations, and statistical analysis.
  • Experience with CDISC data structures, such as SDTM and ADaM.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

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