Edwards Lifesciences
Principal, Statistical Programming
Edwards Lifesciences, Irvine, California, United States, 92713
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.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. 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:
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 statisticianLead in programming analysis datasetsProvide programming expertise on ad hoc data requests in collaboration with project statisticianDevelop 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 reviewMentor, coach, and provide guidance to junior-level programmersCollaborate with CDM to review draft CRFs (Case Report Form), databases and perform edit checksPartner with clinical data management team to ensure that the databases is defined consistency across clinical trialsParticipate 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 LeadershipWhat you'll need (Required):Bachelor's Degree in in Statistics, Mathematics, Computer Science or related field, with 6 years experience of previous experience in statistical analysis Required orMaster's Degree or equivalent in in Statistics Mathematics, Computer Science or related field with 5 years of experience of previous experience Required orPh.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 ExcelExcellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skillsKeeps abreast of new developments in statistics and regulatory guidanceExtensive understanding and knowledge relevant to statistical programmingProven 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 settingExcellent problem-solving, organizational, analytical and critical thinking skillsStrong leadership skills and ability to influence changeAbility to provide training and coaching to lower level employeesExperience in facilitating change, including collaboration with management and executive stakeholdersStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast-paced environmentMust be able to work in a team environment, including serving as consultant to managementAbility to interact with suppliers, vendors and/or customersAdhere 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
For California, Colorado, New York City and Washington, 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., 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.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. 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:
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 statisticianLead in programming analysis datasetsProvide programming expertise on ad hoc data requests in collaboration with project statisticianDevelop 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 reviewMentor, coach, and provide guidance to junior-level programmersCollaborate with CDM to review draft CRFs (Case Report Form), databases and perform edit checksPartner with clinical data management team to ensure that the databases is defined consistency across clinical trialsParticipate 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 LeadershipWhat you'll need (Required):Bachelor's Degree in in Statistics, Mathematics, Computer Science or related field, with 6 years experience of previous experience in statistical analysis Required orMaster's Degree or equivalent in in Statistics Mathematics, Computer Science or related field with 5 years of experience of previous experience Required orPh.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 ExcelExcellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skillsKeeps abreast of new developments in statistics and regulatory guidanceExtensive understanding and knowledge relevant to statistical programmingProven 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 settingExcellent problem-solving, organizational, analytical and critical thinking skillsStrong leadership skills and ability to influence changeAbility to provide training and coaching to lower level employeesExperience in facilitating change, including collaboration with management and executive stakeholdersStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast-paced environmentMust be able to work in a team environment, including serving as consultant to managementAbility to interact with suppliers, vendors and/or customersAdhere 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
For California, Colorado, New York City and Washington, 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., 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.