Director, Biostatistics

Edwards Lifesciences; Minneapolis (MN); On-site; USD 205,000 - 255,000; Full time

Job summary

An established industry player is seeking a Director of Biostatistics to lead a dynamic team in the innovative field of medical technology. This role is pivotal in shaping clinical study designs and data analyses that drive new product innovations. You will collaborate closely with cross-functional teams and stakeholders, ensuring statistical integrity and fostering a culture of excellence and growth within the biostatistics team. Join this inspiring journey to enhance patient outcomes through pioneering technologies and make a meaningful impact on lives. If you're passionate about data and leadership in a fast-paced environment, this opportunity is perfect for you.

Qualifications

• Ph.D. or Master’s in Statistics/Biostatistics required.
• Extensive biostatistical experience with clinical trials data.
• Proven leadership managing a biostatistics team.

Responsibilities

• Lead a team of biostatisticians in clinical study design.
• Manage biostatistics team and oversee financial budgets.
• Provide statistical expertise to internal and external stakeholders.

Skills

Biostatistics

Statistical Programming (SAS, R)

Clinical Trial Design

Leadership

Data Analysis

Communication Skills

Project Management

Education

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

Tools

Microsoft Office Suite

Job description

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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...

• Lead a team of biostatisticians, shaping clinical study design and data analysis to drive new product innovation
• Provide technical and strategic leadership for multiple complex clinical programs in collaboration with cross-functional teams
• Manage and oversee the biostatistics team, including financial budget responsibilities to optimize research efforts
• Define statistical methodologies and real-world evidence strategies, influencing research publication and regulatory success
• Act as core team member/lead biostatistician for assigned clinical trials, ensuring statistical integrity and impact
• Develop and implement talent development plans, fostering growth and leadership within the biostatistics team
• Guide broad, complex biostatistics strategies, including negotiations with internal and external stakeholders
• Drive process improvement initiatives, enhancing efficiency across biostatistics and cross-functional areas
• Create and implement SOPs, processes, and standards, ensuring compliance, accuracy, and optimization
• Plan and manage high-impact activities, mitigating risks and resolving issues in collaboration with cross-functional teams
• Provide statistical expertise to internal and external stakeholders, including marketing, health economics, and reimbursement teams
• Oversee resource analysis and planning to ensure optimal support for biostatistics functions
• Accountable for clinical trials assigned to direct reports, ensuring study integrity and success
• 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 trials 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.
• Demonstrated ability to lead and manage teams, providing coaching, feedback, and partnering on all aspects of employee relations; Support and engage team members at all levels, fostering growth, teamwork, innovation and shared success
• Meticulous attention to detail, ensuring precision and compliance in statistical analyses and reporting
• Professional presence across all organizational levels, with the ability to escalate issues proactively
• Thrives in a fast-paced, dynamic environment, adapting to evolving priorities and business needs
• Frequent interactions with senior stakeholders, influencing operational decisions and strategic direction
• Lead technical meetings and briefings, engaging both internal and external representatives
• Develop relationships and cross-functional partnerships to enhance best practices and collaboration, strategically driving global enterprise system implementations
• Commitment to quality client service, responding proactively to stakeholder needs and challenges
• Influence organizational change through strong relationships and data-driven insights
• Strong ability to drive change and gain consensus in complex or sensitive situations
• Expertise in statistical programming (SAS and/or R) to drive cutting-edge clinical analyses
• Strong proficiency in Microsoft Office Suite to support analytical and reporting functions
• Will adhere to all company rules and safety protocols, ensuring a culture of health, safety, and environmental responsibility
  
  

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $205,000 to $255,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Medical Equipment Manufacturing

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