Director, Biostatistics

Edwards Lifesciences; United States; Remote; USD 205,000 - 255,000; Full time

Job summary

Join a forward-thinking company that is dedicated to improving patient outcomes through innovative clinical solutions. In this impactful role, you will lead a dynamic team of biostatisticians, driving the design and execution of clinical studies that shape the future of healthcare. Collaborating closely with cross-functional teams, you will provide strategic leadership while ensuring the integrity of clinical trials. This position offers a unique opportunity to influence real-world evidence generation and contribute to groundbreaking medical advancements. If you are passionate about data-driven insights and making a difference in patients' lives, this is the perfect opportunity for you.

Qualifications

• Extensive biostatistical experience applying complex methodologies.
• Proven leadership managing a team of direct reports in biostatistics.

Responsibilities

• Lead a team of biostatisticians for clinical study design and data analysis.
• Define statistical methodologies and real-world evidence strategies.

Skills

Biostatistics

Statistical Programming (SAS and/or R)

Clinical Trial Design

Data Analysis

Leadership

Communication Skills

Negotiation Skills

Education

Ph.D. or Master’s degree in Statistics or Biostatistics

Tools

Microsoft Office Suite

Job description

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

You will make an impact by...

1. Lead a team of biostatisticians, shaping clinical study design and data analysis to drive new product innovation
2. Provide technical and strategic leadership for multiple complex clinical programs in collaboration with cross-functional teams
3. Manage and oversee the biostatistics team, including financial budget responsibilities to optimize research efforts
4. Define statistical methodologies and real-world evidence strategies, influencing research publication and regulatory success
5. Act as core team member/lead biostatistician for assigned clinical trials, ensuring statistical integrity and impact
6. Develop and implement talent development plans, fostering growth and leadership within the biostatistics team
7. Guide broad, complex biostatistics strategies, including negotiations with internal and external stakeholders
8. Drive process improvement initiatives, enhancing efficiency across biostatistics and cross-functional areas
9. Create and implement SOPs, processes, and standards, ensuring compliance, accuracy, and optimization
10. Plan and manage high-impact activities, mitigating risks and resolving issues in collaboration with cross-functional teams
11. Provide statistical expertise to internal and external stakeholders, including marketing, health economics, and reimbursement teams
12. Oversee resource analysis and planning to ensure optimal support for biostatistics functions
13. Accountable for clinical trials assigned to direct reports, ensuring study integrity and success
14. Other incidental duties, contributing to additional initiatives shaping the success of medical device development

What you'll need (Required):

• Ph.D. or Master’s degree (or equivalent) in Statistics, Biostatistics, or a related field
• Extensive biostatistical experience applying complex methodologies and analyzing clinical trial data
• Extensive experience on publications and real-world evidence generation
• Proven leadership managing a team of direct reports, driving innovation and excellence in biostatistics

Preferred Qualifications:

• Deep expertise in clinical trial design, applying advanced methodologies to solve complex challenges
• Extensive experience in statistical methodology, publications, and real-world evidence generation
• Strategic understanding of biostatistics processes and systems, ensuring optimal application across projects
• Proven leadership in project management, delivering successful outcomes across complex initiatives
• Exceptional communication and negotiation skills, leveraging data-driven insights to influence decisions and achieve optimal business outcomes.

Additional details about company benefits, salary range, equal opportunity employment statement, and COVID vaccination policy are already well-presented and do not require refinement.