Edwards Lifesciences

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

principal biostatistician

Throughout our history, Edwards has helped transform the way physicians monitor and take preventative measures for cardio patients. Our Critical Care business unit specializes in advanced hemodynamic monitoring solutions, including artificial intelligence algorithms to provide predictive readings to clinicians, helping them get patients home to their families faster. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. 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: <ul><li>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</li><li>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</li><li>Representing Biostatistics on project/study teams and coordinate/communicate with management and KOLS regarding project/study status and timeline update</li><li>Providing statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team</li><li>Compiling technical documents for internal and external audits</li><li>Collaborating to develop case report forms and clinical database ensuring quality data collection</li><li>Leading efforts of data analysis for data monitoring committee as needed </li></ul>What you will need (Required): <ul><li>Ph.D. in Biostatistics, Statistics or equivalent, Plus 2 years of previous analytical experience in clinical trials setting</li><li>Master's Degree in Biostatistics, Statistics or equivalent, Plus 5 years of previous analytical experience in clinical trials setting </li></ul>What else we look for (Preferred): <ul><li>Experience as a biostatistician working in the medical device setting preferred</li><li>Extensive understanding in statistical methodologies related to clinical trial designs, SAP development, statistical modeling and data analyses</li><li>Exposure to Bayesian Methodologies preferred</li><li>Extensive understanding of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to the Medical Device research setting</li><li>Excellent written and verbal communication skills and interpersonal skills including negotiating and relationship management skills</li><li>Experience in facilitating change, including collaboration with management and executive stakeholders; ability to influence change</li><li>Excellent problem-solving, organizational, analytical and critical thinking skills</li><li>Proven expertise in SAS</li><li>Experience with other software packages (e.g., R, Python)</li><li>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 </li></ul>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 $126,000 to $178,000(highly experienced). 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 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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