- 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
- Ph.
- Master's Degree in Biostatistics, Statistics or equivalent, Plus 5 years of previous analytical experience in clinical trials setting
- 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
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Principal Biostatistician, Critical Care, Remote, United States - Colorado, United States - Edwards Lifesciences Corp
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.
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:
What you will need (Required):
What else we look for (Preferred):
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.
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world.
As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role.
If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination.In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
