Principal Biostatistician, THV

Principal, Biostatistician- Transcatheter Heart Valve

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.

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.

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, with 2 years of previous analytical experience in clinical affairs setting

• The position is office based on our beautiful 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.

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