Edwards Lifesciences
Sr Principal Biostatistician, THV
Edwards Lifesciences, Irvine, California, United States, 92713
Senior 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 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 at our beautiful headquarters in
Irvine, California
and we will support relocation cost for a qualified candidate.
More details about our main campus here: https://www.edwards.com/careers/locations/irvineYou will make an impact by...Innovating as the statistical lead on multiple clinical trials, including leading the coordination of analyses for study report and other documents and provide programming and validation support of these analyses
Collaborating with core stakeholders to provide statistical expertise in support of multiple new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed
Representing Biostatistics on multiple project/study teams and
coordinate/communicate
with management and other team members regarding project/study status and timeline update
Researching and recommending novel statistical methodology and/or approaches to internal team and/or cross functional leaders, KOLs
Providing statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and
publication/presentation
efforts related to the project team
Compiling technical documents for internal and external audits
Contributing 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)
Leading the efforts of data analysis for data monitoring committee as needed
Mentoring junior statisticians and work with management in resource allocation and budget/timeline development activities
What you'll need (Required):PhD in Statistics, Biostatistics, or related field , Plus 4 years of previous analytical experience in clinical trials Required OR
Master's Degree in Statistics, Biostatistics, or related field, Plus 7 years of previous analytical experience in clinical trials Required
What else we look for (Preferred):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
Proven expertise in SAS required; experience using other software packages (e.g., R, S-Plus) preferred
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Ability to work successfully in a team environment, including participating and presenting at meetings, including with external representatives
Ability to provide guidance to others on area of expertise
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 $190,000 to $205,000 (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.
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This position is office based at our beautiful headquarters in
Irvine, California
and we will support relocation cost for a qualified candidate.
More details about our main campus here: https://www.edwards.com/careers/locations/irvineYou will make an impact by...Innovating as the statistical lead on multiple clinical trials, including leading the coordination of analyses for study report and other documents and provide programming and validation support of these analyses
Collaborating with core stakeholders to provide statistical expertise in support of multiple new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed
Representing Biostatistics on multiple project/study teams and
coordinate/communicate
with management and other team members regarding project/study status and timeline update
Researching and recommending novel statistical methodology and/or approaches to internal team and/or cross functional leaders, KOLs
Providing statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and
publication/presentation
efforts related to the project team
Compiling technical documents for internal and external audits
Contributing 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)
Leading the efforts of data analysis for data monitoring committee as needed
Mentoring junior statisticians and work with management in resource allocation and budget/timeline development activities
What you'll need (Required):PhD in Statistics, Biostatistics, or related field , Plus 4 years of previous analytical experience in clinical trials Required OR
Master's Degree in Statistics, Biostatistics, or related field, Plus 7 years of previous analytical experience in clinical trials Required
What else we look for (Preferred):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
Proven expertise in SAS required; experience using other software packages (e.g., R, S-Plus) preferred
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Ability to work successfully in a team environment, including participating and presenting at meetings, including with external representatives
Ability to provide guidance to others on area of expertise
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 $190,000 to $205,000 (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.
#J-18808-Ljbffr