Principal Biostatistician job opportunity at Edwards Lifesciences Corporation.

Home Jobs In United States Of America Tag: Job Principal Biostatistician position at Edwards Lifesciences Corporation


DatePosted 30+ Days Ago bot
Edwards Lifesciences Corporation Principal Biostatistician
Experience: 2-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeOND
loacation USA - California – Irvine, United States Of America
loacation USA - Californ..........United States Of America

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic 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. 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): Survival analysis experience Proven expertise in SAS Experience using other software packages (e.g., R, S-Plus) Statistical Analysis Plans (SAP) 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 Keeps abreast of new developments in statistics and regulatory guidance Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting 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 $129,000 to $182,000 (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.

Other Ai Matches

Field Clinical Specialist TMTT - Ontario Applicants are expected to have a solid experience in handling Job related tasks
Smart Factory Solutions Architect Applicants are expected to have a solid experience in handling Job related tasks
Associate Specialist, Physician Training Applicants are expected to have a solid experience in handling Physician Training related tasks
Strategy Data Analyst Applicants are expected to have a solid experience in handling Job related tasks
Second Shift Entry Level Assembler $18.00 Applicants are expected to have a solid experience in handling Job related tasks
Associate Specialist, Talent Acquisition Applicants are expected to have a solid experience in handling Talent Acquisition related tasks
Executive Assistant Applicants are expected to have a solid experience in handling Job related tasks
Mgr, Commercial Data Analytics - AI/ML Applicants are expected to have a solid experience in handling Commercial Data Analytics - AI/ML related tasks
Senior Director, Manufacturing Applicants are expected to have a solid experience in handling Manufacturing related tasks
Sr Mgr, Congress Mgmt Applicants are expected to have a solid experience in handling Congress Mgmt related tasks
Senior Assistant- Transcatheter Heart Valve Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Senior Red Team Operator Applicants are expected to have a solid experience in handling Job related tasks
Marketing Manager, SEA Surgical Applicants are expected to have a solid experience in handling SEA Surgical related tasks
Quality Engineer I Applicants are expected to have a solid experience in handling Job related tasks
Intern, Quality Assurance Applicants are expected to have a solid experience in handling Quality Assurance related tasks
Enterprise Risk Management Intern, Summer 2026 Applicants are expected to have a solid experience in handling Summer 2026 related tasks
Engineer I, Manufacturing Quality Assurance Applicants are expected to have a solid experience in handling Manufacturing Quality Assurance related tasks
PR & Campaigning Lead Applicants are expected to have a solid experience in handling Job related tasks
Manager, Finance Applicants are expected to have a solid experience in handling Finance related tasks
Physician Proctor, M.D. Applicants are expected to have a solid experience in handling M.D. related tasks
Head of Software & Digital Platforms Applicants are expected to have a solid experience in handling Job related tasks
Global Health Economics & Reimbursement Intern, Summer 2026 Applicants are expected to have a solid experience in handling Summer 2026 related tasks
Director, Program Management, Advanced Innovation & Technologies Applicants are expected to have a solid experience in handling Program Management, Advanced Innovation & Technologies related tasks