Principal, Biostatistician- Transcatheter Heart ValveAortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.Represent the THV 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.This position is office based on our beautiful campus in Irvine, California. We will support relocation cost for a qualified candidate.You will make an impact by
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
Collaborate 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
Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team
Compile technical documents for internal and external audits
Contribute 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)
Collaborate on developing case report forms and clinical database to ensure quality data collection
Lead the efforts of data analysis for data monitoring committee as needed
What you'll need (Required):
Ph.D. in Statistics or Biostatistics, Plus 2 years of previous analytical experience in clinical affairs setting
Master's Degree in Statistics or Biostatistics, Plus 5 years of previous analytical experience in clinical affairs setting
Qualified candidates must be able to work onsite at our main campus in Irvine, California. We will support relocation costs for a qualified candidate who currently resides 50 miles or more from our Irvine main campus.
What else we look for (Preferred):
Understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
Understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
Proven expertise in SAS and R
Experience using PASS or EAST
Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
Keeps abreast of new developments in statistics and regulatory guidance
Excellent problem-solving, organizational, analytical and critical thinking skills
Strong leadership skills and ability to influence change
Ability to provide training and coaching to lower level employees
Experience in facilitating change, including collaboration with management and executive stakeholders
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Ability to work in a team environment, including serving as consultant to management
Ability to interact with suppliers, vendors and/or customers
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.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).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.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.