Senior Principal Biostatistician - Edwards Lifesciences
San Diego, CA
About the Job
Senior Principal Biostatistician - Advanced Technology (AT)
Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.
As a Senior Principal Biostatistician in AT, you 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'll make an impact:
+ Provide impact as the statistical lead on multiple clinical trials
+ Lead the coordination of analyses for study report and other documents
+ Provide programming and validation support of these analyses
+ Collaborate 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
+ Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
+ Research and recommend novel statistical methodology and/or approaches on clinical trial design
+ Provide statistical expertise and guidance to internal and external stakeholders 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)
+ Lead the efforts of data analysis for data monitoring committee as needed
+ Mentor junior statisticians and work with management in resource allocation and budget/timeline development activities
What you'll need (Required):
+ Master's Degree or equivalent in Statistics, Biostatistics, or related field, Plus 7 years of previous analytical experience in clinical trials
+ Ph.D. or equivalent in Statistics, Biostatistics, or related field, Plus 4 years of previous analytical experience in clinical trials
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
+ Keeps abreast of new developments in statistics and regulatory guidance
+ Experience in facilitating change, including collaboration with management
+ and executive stakeholders
+ Ability to provide training and coaching to junior level employees
+ Strict attention to detail
+ 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 in a team environment, including participating and presenting at meetings, including with external representatives
+ Ability to provide guidance to others on area of expertise
+ Proven expertise in SAS required; experience using other software packages (e.g., R, S-Plus)
+ Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
+ 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 $145,000 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.
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.
Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.
As a Senior Principal Biostatistician in AT, you 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'll make an impact:
+ Provide impact as the statistical lead on multiple clinical trials
+ Lead the coordination of analyses for study report and other documents
+ Provide programming and validation support of these analyses
+ Collaborate 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
+ Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
+ Research and recommend novel statistical methodology and/or approaches on clinical trial design
+ Provide statistical expertise and guidance to internal and external stakeholders 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)
+ Lead the efforts of data analysis for data monitoring committee as needed
+ Mentor junior statisticians and work with management in resource allocation and budget/timeline development activities
What you'll need (Required):
+ Master's Degree or equivalent in Statistics, Biostatistics, or related field, Plus 7 years of previous analytical experience in clinical trials
+ Ph.D. or equivalent in Statistics, Biostatistics, or related field, Plus 4 years of previous analytical experience in clinical trials
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
+ Keeps abreast of new developments in statistics and regulatory guidance
+ Experience in facilitating change, including collaboration with management
+ and executive stakeholders
+ Ability to provide training and coaching to junior level employees
+ Strict attention to detail
+ 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 in a team environment, including participating and presenting at meetings, including with external representatives
+ Ability to provide guidance to others on area of expertise
+ Proven expertise in SAS required; experience using other software packages (e.g., R, S-Plus)
+ Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
+ 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 $145,000 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.
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.
Source : Edwards Lifesciences
