Edwards Lifesciences
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Director, Biostatistics
role at
Edwards Lifesciences
Job Summary 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.
Responsibilities
Leading a team of biostatisticians, shaping clinical study design and data analysis to drive new product innovation
Providing technical and strategic leadership for multiple complex clinical programs, collaborating with cross-functional teams
Overseeing the biostatistics team, managing budgets to maximize research impact
Defining statistical methodologies and real-world evidence strategies, influencing research publications and regulatory success
Acting as the lead biostatistician for assigned clinical trials, ensuring statistical integrity and meaningful insights
Developing and implementing talent development plans, fostering leadership within the biostatistics team
Driving complex biostatistics strategies, engaging with both internal and external stakeholders
Spearheading process improvement initiatives to enhance efficiency across biostatistics and cross-functional areas
Establishing and optimizing SOPs, processes, and standards to ensure accuracy and compliance
Managing high-impact activities, proactively addressing risks and resolving issues collaboratively
Providing statistical expertise to key stakeholders, including marketing, health economics, and reimbursement teams
Overseeing resource analysis and planning, ensuring optimal support for biostatistics functions
Ensuring clinical trial integrity and success for direct reports and assigned studies
Contributing to additional initiatives that shape the future of medical device development
Qualifications (Required)
Ph.D. or equivalent in Statistics, Biostatistics, or related field with previous analytical experience in clinical trials
Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions such as hiring/firing authority and partnering with HR on all aspects of employee relations
Preferred Qualifications
Proven leadership managing teams and projects, driving innovation, excellence, and successful delivery of complex initiatives
Extensive biostatistical experience applying complex methodologies and analyzing clinical trials data
Deep expertise in clinical trial design and statistical methodology, solving complex challenges and driving innovation
Extensive experience on publications and real‑world evidence generation, ensuring meaningful impact in clinical outcomes
Strategic understanding of biostatistics processes and systems, enabling optimal application across multiple projects
Exceptional communication and negotiation skills, leveraging data‑driven insights to influence decision‑making
Proven ability to coach, support, and manage direct reports across all aspects of employee relations
Meticulous attention to detail ensuring accuracy, compliance, and integrity in statistical analyses and reporting
Professional presence across all organizational levels, proactively addressing and escalating issues as needed
Ability to thrive in fast‑paced, dynamic environments and adapt to evolving priorities
Regular engagement with senior stakeholders to shape operational decisions and influence strategic direction
Lead technical meetings and briefings, collaborating with internal and external representatives to drive initiatives forward
Build strong relationships and cross‑functional partnerships, establishing best practices and advancing global enterprise systems
Commitment to quality client service, responding proactively to stakeholder needs and challenges
Key role in influencing organizational change, leveraging relationships and insights to drive transformation
Strong change leadership skills, capable of driving consensus in complex or sensitive situations
Expertise in statistical programming (SAS and/or R) for advanced clinical analyses and impactful research
Strong proficiency in Microsoft Office Suite to support analytical and reporting functions
Remote work with 5‑10% travel to our corporate office in Irvine, California
Compensation & Benefits The base pay range for this position is $205,000 to $255,000 (highly experienced). Applications will be accepted while this position is posted on our Careers website.
We offer competitive salaries, performance‑based incentives, and a wide variety of benefit programs to address the diverse individual needs of our employees and their families.
EEO Statement 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.
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Director, Biostatistics
role at
Edwards Lifesciences
Job Summary 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.
Responsibilities
Leading a team of biostatisticians, shaping clinical study design and data analysis to drive new product innovation
Providing technical and strategic leadership for multiple complex clinical programs, collaborating with cross-functional teams
Overseeing the biostatistics team, managing budgets to maximize research impact
Defining statistical methodologies and real-world evidence strategies, influencing research publications and regulatory success
Acting as the lead biostatistician for assigned clinical trials, ensuring statistical integrity and meaningful insights
Developing and implementing talent development plans, fostering leadership within the biostatistics team
Driving complex biostatistics strategies, engaging with both internal and external stakeholders
Spearheading process improvement initiatives to enhance efficiency across biostatistics and cross-functional areas
Establishing and optimizing SOPs, processes, and standards to ensure accuracy and compliance
Managing high-impact activities, proactively addressing risks and resolving issues collaboratively
Providing statistical expertise to key stakeholders, including marketing, health economics, and reimbursement teams
Overseeing resource analysis and planning, ensuring optimal support for biostatistics functions
Ensuring clinical trial integrity and success for direct reports and assigned studies
Contributing to additional initiatives that shape the future of medical device development
Qualifications (Required)
Ph.D. or equivalent in Statistics, Biostatistics, or related field with previous analytical experience in clinical trials
Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions such as hiring/firing authority and partnering with HR on all aspects of employee relations
Preferred Qualifications
Proven leadership managing teams and projects, driving innovation, excellence, and successful delivery of complex initiatives
Extensive biostatistical experience applying complex methodologies and analyzing clinical trials data
Deep expertise in clinical trial design and statistical methodology, solving complex challenges and driving innovation
Extensive experience on publications and real‑world evidence generation, ensuring meaningful impact in clinical outcomes
Strategic understanding of biostatistics processes and systems, enabling optimal application across multiple projects
Exceptional communication and negotiation skills, leveraging data‑driven insights to influence decision‑making
Proven ability to coach, support, and manage direct reports across all aspects of employee relations
Meticulous attention to detail ensuring accuracy, compliance, and integrity in statistical analyses and reporting
Professional presence across all organizational levels, proactively addressing and escalating issues as needed
Ability to thrive in fast‑paced, dynamic environments and adapt to evolving priorities
Regular engagement with senior stakeholders to shape operational decisions and influence strategic direction
Lead technical meetings and briefings, collaborating with internal and external representatives to drive initiatives forward
Build strong relationships and cross‑functional partnerships, establishing best practices and advancing global enterprise systems
Commitment to quality client service, responding proactively to stakeholder needs and challenges
Key role in influencing organizational change, leveraging relationships and insights to drive transformation
Strong change leadership skills, capable of driving consensus in complex or sensitive situations
Expertise in statistical programming (SAS and/or R) for advanced clinical analyses and impactful research
Strong proficiency in Microsoft Office Suite to support analytical and reporting functions
Remote work with 5‑10% travel to our corporate office in Irvine, California
Compensation & Benefits The base pay range for this position is $205,000 to $255,000 (highly experienced). Applications will be accepted while this position is posted on our Careers website.
We offer competitive salaries, performance‑based incentives, and a wide variety of benefit programs to address the diverse individual needs of our employees and their families.
EEO Statement 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.
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