Top 4177 Medical device validation Jobs

Principal Biostatistician (Remote)
Everest Clinical Research —Bridgewater, NJ
- $150,000 - $200,000 a year
- Remote
- 7 years
- Master's degree
- Continuous improvement
- AD&D insurance
- Disability insurance
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Validation Engineer/CSV Engineer
Katalyst Healthcares & Life Sciences —Walnut Creek, CA
- Multiple hires
- Engineering
- Mid-level
- Software development
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Medical Device Workflow & Validation Lead (Remote, Continental United States)
ICA.ai —Arlington, VA
- $130,000 - $160,000 a year
- Full-time
- Remote
- Analysis skills
- US work authorization
- Senior level
- Disability insurance
- Health insurance
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14d
Manager, Medical Device Labeling and Operations
LivaNova —Remote
- $120,000 - $145,000 a year
- Full-time
- 8 years
- Bachelor's degree
- Travel
- Employee stock purchase plan
- Health insurance
Medical Device Validation Engineer-2
Realign LLC —Danvers, MA
- $151,800 a year
- Full-time
- DevOps
- Mid-level
Computer System Validation Engineer - Medical Device Equipment & Regulations
Macpower Digital Assets Edge Private Limited —San Juan, PR
- $45 an hour
- Organizational skills
- Software development
- Senior level
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Medical Device Decontamination SME
Tunnell Government Services —Washington, DC
- Remote
- Bachelor of Science
- 11+ years
- Bachelor's degree
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Medical Device V&V engineers
Katalyst Healthcares & Life Sciences —Avenel, NJ
- Contract
- 5 years
- English
- Analysis skills
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Sr Mgr, QA/Quality Engineer, Device & Combination Products
ESPERION THERAPEUTICS INC —Ann Arbor, MI
- $166,500 - $175,000 a year
- Remote
- Laboratory experience
- Microsoft Office
- Travel
- Paid holidays
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Clinical Outcomes Assessment Rater Trainer
ICON Plc —Blue Bell, PA
- Full-time
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- Nursing
- Mid-level
- Business development
- Disability insurance
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8d
Senior Validation Engineer / Project Lead (Medical Devices)
Katalyst Healthcares & Life Sciences —Salt Lake City, UT
- Contract
- Hybrid work
- Management
- Senior level
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Senior R&D Engineer - Medical Device #3410
Enhanced Compliance Inc. —Remote
- Full-time
- 5 years
- Engineering
- Analysis skills
Medical Device Design Controls & Remediation Engineer
Amaris Consulting —Bothell, WA
- English
- Mid-level
- 3 years
9d
CardioMed Device Consultants- Principal Consultant
BDC Laboratories —Edgewater, MD
- Full-time
- Remote
- Public speaking
- Mentoring
- Senior level
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Validation Engineer
Katalyst Healthcares & Life Sciences —Minneapolis, MN
- Contract
- Hybrid work
- 5 years
- Engineering
- Analysis skills
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Instrumentation Software Validation Analyst
Katalyst Healthcares & Life Sciences —Cincinnati, OH
- Contract
- Computer Science
- 5 years
- Laboratory experience
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IVD Documentation Scientist, Manufacturing and Medical Device (Contract)
Delfi Diagnostics —Palo Alto, CA
- $62 - $80 an hour
- Contract
- Hybrid work
- Bachelor of Science
- Bachelor's degree
- Doctor of Philosophy
5d
Validation Lifecycle & Periodic Review Program Manager
Validation & Engineering Group, Inc —Remote
- Full-time
- Hybrid work
- Engineering
- 3 years
- Senior level
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CSV Analyst
Katalyst Healthcares & Life Sciences —Dallas, TX
- Contract
- Hybrid work
- Computer Science
- 5 years
- Laboratory experience
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Medical Device Engineer or Materials Scientist (Implantable Device Degradation)
Tunnell Government Services —Washington, DC
- Full-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- System design
Quick Apply
4d

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Principal Biostatistician (Remote)

Everest Clinical Research -
Bridgewater, NJ

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Job Details

$150,000 - $200,000 a year

Benefits

AD&D insurance
Disability insurance
Health insurance
Dental insurance
401(k)
Tuition reimbursement
Paid time off
Pension plan
Work from home
Employee assistance program
Vision insurance
Gym membership

Qualifications

Drug development research projects
Statistics
Medical writing
7 years
Content creation for technical audiences
Statistics
Operations management
Biostatistics-based research
Medical statistical report preparation
Data validation techniques
Team leadership
Technical documentation
Coaching
Data quality assurance
Drug development research
Scientific posters
Data reporting
Metrics Reporting
Master's degree
Data quality management
Team development
Quality control management
Professional development support
Statistics research
Ph.D. in statistics
Continuous improvement
Doctor of Philosophy
Clinical program data analysis
Statistical modeling
Compliance documentation

Full Job Description

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Principal Biostatisticians for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.

Key Accountabilities:

Work with a leader of the Statistical Operations management team to manage clinical trial programs/projects from one or multiple clients. Provide day to day technical and operational leadership to project teams supporting these programs/projects.

Provide statistical oversight on projects in the assigned drug development programs/projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting.

Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program/projects.

Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.

Serve as a primary biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels.

Review and provide input to clinical data management deliverables, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan.

Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Perform peer review of SAPs and other technical documents written by others.

Perform hands on statistical analysis and modeling, and maintains expertise in state-of-the-art statistical methodology and regulatory requirements.

Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians, ensuring that core results for each responsible trial are complete and accurate. Perform overall Quality Control review on statistical deliverables before they are released to the clients.

Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.

Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations.

Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.

Interact with regulatory agencies and support sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency’s requirement/expectation (e.g., CDISC).

Perform statistical and programming resource management, capacity analysis, benchmarking and metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents.

Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

Qualifications and Experience:

A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 7 years of relevant experience or a Master’s degree in these fields with at least 10 years of relevant experience, with demonstrated exceptional ability and performance.

Benefits & Compensation:

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement / pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $150,000 - $200,000.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com (http://www.ecrscorp.com).

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

#LI-Remote
#LI-TK1

#INDHP

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

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Refine Your Search

medical device validation jobs

Principal Biostatistician (Remote)

Validation Engineer/CSV Engineer

Medical Device Workflow & Validation Lead (Remote, Continental United States)

Manager, Medical Device Labeling and Operations

Medical Device Validation Engineer-2

Computer System Validation Engineer - Medical Device Equipment & Regulations

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Medical Device V&V engineers

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Instrumentation Software Validation Analyst

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Medical Device Engineer or Materials Scientist (Implantable Device Degradation)

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