Principal, Statistical Programming - Edwards Lifesciences
Irvine, CA
About the Job
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.
How you’ll make an impact:
+ Independently lead studies; being able to use SAS or R to build datasets and tables, figures and listings for clinical trials
+ The Principal Statistical Programming Leader will Develop, test, validate, document, maintain and execute programs in SAS and serve as lead programmer. He/she will take primary role in review and validation of SAS programs created by more junior-level programmers. In addition, will ensure that all appropriate documentation is appropriately filled out and approved.
+ Provide programming expertise on one or more clinical trials in programming, documentation, validation and review of summary tables, data listings, and graphs for inclusion in clinical reports or presentations in collaboration with project statistician
+ Lead in programming analysis datasets
+ Provide programming expertise on ad hoc data requests in collaboration with project statistician
+ Develop program specifications and design documents in partnership with project statistician.
+ Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review
+ Mentor, coach, and provide guidance to junior-level programmers
+ Collaborate with CDM to review draft CRFs (Case Report Form), databases and perform edit checks
+ Partner with clinical data management team to ensure that the databases is defined consistency across clinical trials
+ Participate in the development of procedures (e.g. SOP development and standardization of output)
+ Assist in compiling technical documents for internal and external audits; Other duties assigned by Leadership
What you'll need (Required):
+ Bachelor's Degree in Statistics, Mathematics, Computer Science or related field, with 6 years experience of previous experience in statistical analysis Required or
+ Master's Degree or equivalent in in Statistics Mathematics, Computer Science or related field, with 5 years experience of previous experience Required or
+ Ph.D. or equivalent in in Statistics Mathematics, Computer Science or related field, with 2 years experience of previous experience Required
What else we look for (Preferred):
+ 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 skill
+ Proven Expertise in SAS Programming
+ CDISC standards SDTM and ADAM Experience
+ Keeps abreast of new developments in statistics and regulatory guidance
+ Extensive understanding and knowledge relevant to statistical programming
+ Proven expertise in SAS and Windows operating systems required; experience using other software packages (e.g., R, S-Plus)
+ Extensive 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
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to manage competing priorities in a fast-paced environment
+ Must be able 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.
The base pay range for this position is $126,000 to $178,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., geographic location, 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.
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.
How you’ll make an impact:
+ Independently lead studies; being able to use SAS or R to build datasets and tables, figures and listings for clinical trials
+ The Principal Statistical Programming Leader will Develop, test, validate, document, maintain and execute programs in SAS and serve as lead programmer. He/she will take primary role in review and validation of SAS programs created by more junior-level programmers. In addition, will ensure that all appropriate documentation is appropriately filled out and approved.
+ Provide programming expertise on one or more clinical trials in programming, documentation, validation and review of summary tables, data listings, and graphs for inclusion in clinical reports or presentations in collaboration with project statistician
+ Lead in programming analysis datasets
+ Provide programming expertise on ad hoc data requests in collaboration with project statistician
+ Develop program specifications and design documents in partnership with project statistician.
+ Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review
+ Mentor, coach, and provide guidance to junior-level programmers
+ Collaborate with CDM to review draft CRFs (Case Report Form), databases and perform edit checks
+ Partner with clinical data management team to ensure that the databases is defined consistency across clinical trials
+ Participate in the development of procedures (e.g. SOP development and standardization of output)
+ Assist in compiling technical documents for internal and external audits; Other duties assigned by Leadership
What you'll need (Required):
+ Bachelor's Degree in Statistics, Mathematics, Computer Science or related field, with 6 years experience of previous experience in statistical analysis Required or
+ Master's Degree or equivalent in in Statistics Mathematics, Computer Science or related field, with 5 years experience of previous experience Required or
+ Ph.D. or equivalent in in Statistics Mathematics, Computer Science or related field, with 2 years experience of previous experience Required
What else we look for (Preferred):
+ 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 skill
+ Proven Expertise in SAS Programming
+ CDISC standards SDTM and ADAM Experience
+ Keeps abreast of new developments in statistics and regulatory guidance
+ Extensive understanding and knowledge relevant to statistical programming
+ Proven expertise in SAS and Windows operating systems required; experience using other software packages (e.g., R, S-Plus)
+ Extensive 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
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to manage competing priorities in a fast-paced environment
+ Must be able 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.
The base pay range for this position is $126,000 to $178,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., geographic location, 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
