Principal Biostatistician, Critical Care - San Diego, United States - Edwards Lifesciences
Description
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.
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.
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 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.
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