Principal Biostatistician

Principal Biostatistician Irvine, CA Job Details Full-time $132,000 - $186,000 a year 1 hour ago Qualifications Project team coordination Microsoft Word FDA submissions Statistics Doctoral degree in statistics Bayesian inference Clinical study protocols and reports Statistics Presentation software Biostatistics-based research Procedural guides SAS Technical documentation New product development R Process improvement SAS language Databases Change management Data quality management ICH guidelines Quality assurance Ph.D. in statistics Doctor of Philosophy Statistical modeling Relationship management Good Clinical Practice Regulatory submissions Quality audits Data validation Training & development Senior level Training Medical affairs Leadership 2 years Communication skills Statistical analysis tools Full Job Description 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. The Principal Biostatistician 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: 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. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience What else we look for (Preferred): Training or publications in Bayesian methodology Expertise in MS Office (Word, PowerPoint, Access, Excel) Strong written/verbal communication and relationship management skills Up-to-date on statistical and regulatory developments Deep knowledge of clinical trial design, statistical modeling, and data analysis Proficient in SAS; experience with R, S-Plus Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices Excellent problem-solving, analytical, and critical thinking skills Proven leadership and ability to influence change Skilled in training/coaching and facilitating organizational change Detail-oriented; able to manage competing priorities in fast-paced environments Professional interaction across all levels; collaborative team player and consultant to management 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 $132,000 - $186,000 (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. E dwards 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.