Director of Biostatistics (Med Device) in Portland, OR

Are you an experienced biostatistics leader with a passion for driving data-driven decision-making in the medical device industry? We are seeking a Director of Biostatistics (Med Device) in Portland, OR to lead statistical strategy, oversee clinical trial data analysis, and ensure regulatory compliance. This role requires a highly skilled professional with expertise in biostatistical methodologies, clinical study designs, and regulatory submissions. If you have a strong background in statistical leadership within medical device clinical research, this is an excellent opportunity to play a critical role in shaping the future of innovative healthcare solutions.

About This Role

The Director of Biostatistics (Med Device) in Portland, OR will lead the biostatistics function, collaborating closely with clinical development, regulatory, and data science teams to design and analyze clinical trials. This position plays a key role in statistical planning, regulatory interactions, and ensuring the integrity of clinical data. The successful candidate will be responsible for developing robust statistical methodologies, providing oversight on trial design, and ensuring compliance with FDA and global regulatory requirements. If you are passionate about using biostatistics to advance medical technology and improve patient outcomes, this role offers the opportunity to make a significant impact in the medical device industry.

Key Responsibilities – Director of Biostatistics (Med Device) in Portland, OR

1. Lead Statistical Strategy for Clinical Trials

Develop and oversee statistical methodologies for clinical trials in compliance with regulatory guidelines.
Ensure statistical plans align with clinical objectives and support product development goals.
Collaborate with cross-functional teams to design trials that generate high-quality, regulatory-compliant data.

2. Oversee Clinical Study Design & Data Analysis

Provide statistical expertise in study design, including sample size calculations and endpoint selection.
Supervise data analysis, interpretation, and reporting of clinical trial results.
Guide the development of statistical models to enhance data-driven decision-making.

3. Ensure Compliance with Regulatory Requirements

Lead statistical sections of regulatory submissions, including FDA, EMA, and other global agencies.
Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and industry best practices.
Act as a key liaison with regulatory agencies regarding biostatistical aspects of submissions and approvals.

4. Develop and Implement Data Management Strategies

Work closely with data management teams to ensure high-quality data collection and integrity.
Develop strategies for handling missing data, outliers, and protocol deviations.
Oversee the use of statistical software and programming tools for efficient data analysis.

5. Drive Innovation in Biostatistics for Medical Devices

Evaluate and implement cutting-edge statistical techniques for adaptive trials and real-world evidence analysis.
Identify opportunities for leveraging AI and machine learning in biostatistics.
Stay updated on emerging trends and advancements in biostatistical research and their applications in medical device development.

6. Mentor and Develop a High-Performing Biostatistics Team

Lead, mentor, and develop a team of biostatisticians, providing training and career development opportunities.
Establish best practices in statistical methodology and data analysis within the organization.
Foster a culture of innovation, collaboration, and scientific rigor in biostatistical research.

7. Collaborate with Key Stakeholders in Clinical Development

Work closely with clinical development, regulatory, and medical affairs teams to align statistical strategies with clinical and business objectives.
Provide statistical input in protocol development, clinical study reports, and publications.
Participate in cross-functional meetings to ensure statistical considerations are integrated throughout product development.

8. Support Publication and Scientific Communication Efforts

Contribute to the development of scientific publications, white papers, and conference presentations.
Ensure statistical analyses are accurately represented in peer-reviewed journals and industry conferences.
Collaborate with external key opinion leaders (KOLs) to validate statistical methodologies and findings.

What The Client is Looking For in You

To excel as the Director of Biostatistics (Med Device) in Portland, OR, you should possess a strong mix of statistical expertise, leadership skills, and regulatory knowledge. The ideal candidate will have:

Advanced Expertise in Biostatistics – A deep understanding of statistical methodologies, study designs, and data analysis techniques specific to clinical trials in the medical device industry.
Regulatory Knowledge & Compliance Experience – Extensive experience in preparing and submitting statistical components for regulatory approvals, including FDA, EMA, and global health authorities.
Leadership & Team Management Skills – The ability to mentor, develop, and lead a team of biostatisticians, fostering a collaborative and high-performance work environment.
Strategic & Analytical Thinking – Strong problem-solving skills, with the ability to design robust statistical strategies that align with business and clinical objectives.
Experience with Clinical Trial Design & Data Interpretation – Proven ability to design and analyze complex clinical studies, ensuring data integrity and statistical rigor.
Proficiency in Statistical Software – Expertise in statistical programming languages such as SAS, R, or Python, along with experience using software for clinical trial analysis.
Excellent Communication & Cross-Functional Collaboration – Strong ability to communicate statistical concepts to non-statistical stakeholders, including clinical teams, regulatory agencies, and executive leadership.
Passion for Medical Innovation – A deep commitment to advancing medical device technology through high-quality clinical research and data-driven insights.

Why This Opportunity Stands Out

This position offers a unique opportunity to play a key role in shaping clinical research and regulatory success in the medical device sector. As the Director of Biostatistics (Med Device) in Portland, OR, you will:

Lead Statistical Innovation in a Cutting-Edge Industry – Work on groundbreaking medical device trials that impact patient care and healthcare solutions worldwide.
Work with a Fast-Growing Medical Technology Company – Join an organization at the forefront of developing innovative medical devices, with a strong pipeline of products.
Engage in High-Impact Regulatory Strategy – Be a crucial part of FDA submissions, ensuring that statistical methodologies meet the highest regulatory standards.
Collaborate with a World-Class Team – Work alongside top clinical researchers, data scientists, and regulatory experts in a dynamic and intellectually stimulating environment.
Enjoy Competitive Compensation & Benefits – Receive an attractive salary package, including performance-based bonuses, equity options, and a comprehensive benefits plan.
Career Growth & Development – Lead a team and drive strategic initiatives that will shape the future of medical device biostatistics.

FAQs About the Role

Q: What industries should I have experience in?
A: You should have extensive experience in biostatistics within the medical device, pharmaceutical, or biotechnology sectors, with a strong focus on clinical trials and regulatory submissions.

Q: What is the required education and experience for this role?
A: A PhD or Master’s degree in Biostatistics, Statistics, or a related field is required. Candidates should have 10+ years of experience in biostatistics, with at least 5 years in a leadership role within the medical device or clinical research industry.

Q: Does this role require regulatory submission experience?
A: Yes, extensive experience in FDA and global regulatory submissions is required, including statistical analysis plans (SAPs), clinical study reports (CSRs), and interactions with regulatory agencies.

Q: Is relocation required for this position?
A: This position is based in Portland, OR, and candidates must be open to relocating or already reside in the area. Relocation assistance may be available for the right candidate.

Q: What statistical software and tools should I be proficient in?
A: Proficiency in SAS, R, Python, and other statistical programming languages is essential. Experience with clinical trial data management systems and regulatory submission tools is highly preferred.

Q: What kind of leadership style is expected?
A: We seek a leader who is strategic, collaborative, and results-driven, with the ability to mentor and inspire a high-performing team of biostatisticians.

Q: What is the expected travel requirement?
A: Some travel may be required for industry conferences, regulatory meetings, and clinical trial oversight, but this role is primarily based in Portland, OR.

Q: How does this role contribute to the company’s success?
A: The Director of Biostatistics (Med Device) in Portland, OR plays a critical role in ensuring the accuracy, integrity, and regulatory compliance of clinical trial data, directly impacting product approvals and market success.

Q: What is the hiring timeline?
A: The company is actively recruiting for this position and aims to complete the hiring process within the next 60–90 days, with onboarding focused on integrating into current and upcoming clinical programs.

What Remuneration Can You Expect from This Job?

As the Director of Biostatistics (Med Device) in Portland, OR, you can expect a highly competitive compensation package that reflects your expertise, leadership, and impact on the company’s clinical and regulatory success. The base salary for this role typically ranges from $180,000 – $250,000 per year, depending on experience, statistical expertise, and prior leadership achievements in the medical device industry.

Beyond the base salary, this position offers performance-based bonuses and incentives tied to key clinical and regulatory milestones, including successful FDA submissions and clinical trial outcomes. For high-performing candidates, equity options or stock grants may be available, allowing participation in the company’s long-term growth.

The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, generous paid time off (PTO), and professional development opportunities such as industry conference attendance and continuing education. Additional benefits may include relocation assistance, travel allowances for regulatory and clinical meetings, and executive-level perks.

This role offers not only lucrative financial rewards but also the opportunity to make a significant impact in the medical device sector while working alongside a talented and driven leadership team.

How to Apply for This Director of Biostatistics (Med Device) Position in Portland, OR

If you are a strategic and results-driven biostatistics leader with a strong background in medical device clinical trials, we invite you to apply for the Director of Biostatistics (Med Device) in Portland, OR. This is a high-impact opportunity to lead statistical innovation, contribute to regulatory success, and drive clinical trial excellence.

To apply, please submit your resume and a cover letter detailing your experience in biostatistics, regulatory submissions, clinical trial design, and leadership in the medical device sector.

This role offers a rewarding career opportunity to lead cutting-edge clinical research, develop advanced statistical methodologies, and contribute to a company that is shaping the future of medical device innovation. Apply today to take the next step in your career as a Director of Biostatistics (Med Device) in Portland, OR!

For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.

Job Category: Director of Biostatistics

Job Type: Full Time

Job Location: Portland