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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.

The Manager Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. Please note that this is a highly technical individual contributor position.

How you will make an impact:

• Taking charge as statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses

• Collaborating with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed

• Representing Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update

• Providing statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team

• Compiling technical documents for internal and external audits

• Contributing to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs)

• Collaborating on developing case report forms and clinical database to ensure quality data collection

• Leading the efforts of data analysis for data monitoring committee as needed

What you'll need (Required):

• Master's Degree or equivalent in Statistics, Biostatistics, or related field, Plus 5 years of previous analytical experience in clinical trial design Required or

• Ph.D. or equivalent in Statistics, Biostatistics, or related field , Plus 2 years of professional experience in clinical trial design Required

What else we look for (Preferred):

• Experience as a biostatistician working in the medical device setting preferred

• Experience with trial simulations for sample size and power calculation

• Extensive understanding in statistical methodologies related to clinical trial designs, statistical modeling, data analyses, development SAP, SOPs, WIMs

• Extensive understanding of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to the Medical Device research setting; Stays up to date with industry trends

• Experience writing CERs under strict timelines

• Experience with Data Monitoring Committee (DMC)/ Data Safety Monitoring Board (DSMB)

• Can effectively manage competing priorities in a fast paced environment and maintain strict attention to detail

• Excellent written and verbal communication skills and interpersonal skills/ capabilities including the following: self-driven, negotiation, leadership, relationship management

• Demonstrates Leadership capabilities including ability to provide training and coaching to more junior level employees and interaction with suppliers, vendors and/or customers

• Experience in facilitating change, including collaboration with all organizational levels including executive stakeholders; ability to influence change

• Excellent problem-solving, organizational, analytical and critical thinking skills

• Proven expertise in SAS; Experience with other software packages (e.g., R, S-Plus)

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

This position can be remote within the United States.

The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment for more patients. . Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement.

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, the base pay range for this position is $130,000 to $170,000 (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.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.