Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you will make an impact:
The Distinguished Biostatistician, TMTT 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.
Statistical lead on multiple and complex clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses while providing consultation on statistical methodology
Collaborate with core stakeholders to provide statistical expertise in support of multiple and complex new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed
Represent Biostatistics on multiple and complex project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
Develop novel statistical methodology and/or approaches
Lead in the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs)
Provide novel statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the project team
Mentor junior statisticians and work with management in resource allocation and budget/timeline development activities
Compile technical documents for internal and external audits
What you'll need (Required):
Master's Degree or equivalent in Statistics, Biostatistics, or related field, 11 years of experience of previous analytical experience in clinical trials
Ph.D. or equivalent in Statistics, Biostatistics, or related field, 8 years of experience
What else we look for (Preferred):
Proficiency in statistical programming languages such as SAS and/or R
Proven expertise 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 with ability to drive achievement of objectives
Keeps abreast of new developments in statistics and regulatory guidance
Expert understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
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
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 (CA), the base pay range for this position is $177,000 to $251,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers 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.