Principal Biostatistician, Critical Care, Remote, United States

For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.

With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.  

As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability. We are well-positioned to build upon our category leadership as we continue to launch new solutions powered by A.I. to clinicians and expand into new care settings.   

So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industry-leading advanced monitoring company we invite you to explore our career opportunities. Those who choose to join us will be part of a ‘once-in-a-lifetime’ journey to improve the quality of care and outcomes for millions of patients around the world.  

Appendix:  

For further detail on the spin-off of Critical Care from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99.

As a Principal Biostatistician with Critical Care, you 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.

How you will make an impact:

• Working as statistical lead on one or more clinical trials by leading 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., 510(k), CE Mark, PMA) and other regulatory documents as needed

• Representing Biostatistics on project/study teams and coordinate/communicate with management and KOLS 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

• Collaborating to develop case report forms and clinical database ensuring quality data collection

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

What you will need (Required):

• Ph.D. in Biostatistics, Statistics or equivalent, Plus 2 years of previous analytical experience in clinical trials setting

• Master's Degree in Biostatistics, Statistics or equivalent, Plus 5 years of previous analytical experience in clinical trials setting

What else we look for (Preferred):

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

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

• Exposure to Bayesian Methodologies preferred

• Extensive understanding of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to the Medical Device research setting

• Excellent written and verbal communication skills and interpersonal skills including negotiating and relationship management skills

• Experience in facilitating change, including collaboration with management and 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, Python)

• 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

Aligning our overall business objecti