Director, Biostatistics

Edwards Lifesciences; Irvine (CA); Remote; USD 205,000 - 255,000; Full time

Job summary

An innovative healthcare company is seeking a skilled Biostatistics Lead to drive clinical study design and data analysis for groundbreaking therapies. This role involves leading a talented team, collaborating with cross-functional partners, and influencing research publication and regulatory success. Join a passionate team dedicated to transforming patient outcomes through advanced statistical methodologies and real-world evidence generation. If you thrive in a fast-paced environment and are eager to make a significant impact in healthcare, this opportunity is for you.

Benefits

Competitive Salaries

Performance-Based Incentives

Diverse Benefits Programs

Qualifications

• Extensive biostatistical experience with clinical trial data.
• Proven leadership in managing biostatistics teams and projects.

Responsibilities

• Lead biostatistics team in clinical study design and data analysis.
• Manage complex clinical programs and ensure statistical integrity.

Skills

Biostatistics

Statistical Methodologies

Clinical Trial Design

Data Analysis

Project Management

Statistical Programming (SAS/R)

Communication Skills

Negotiation Skills

Education

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

Tools

SAS

R

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...

• 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 applyingcomplex methodologiesand analyzingclinical 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.

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