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:

Lead on clinical studies and manage a team and oversee statistical programming activities within an assigned BU.Lead a team of programmers in the development of program specifications and design documents in partnership with project statistician. Lead in programming analysis datasets in multiple clinical trials. May also function as a lead statistical programmer for specific projects as needed.Manage and oversee the work of a small team of statistical programmers and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the departmentProvide programming expertise on multiple clinical trials for analysis for inclusion in clinical study reports, presentations, or select publications in collaboration with project statisticianProvide programming expertise on complex ad hoc data requests in collaboration with project statisticianIdentify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external partiesEnsure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and reviewLead a team of programmers in collaboration with cross-functional teams to ensure that database and external data source when applicable meet analysis requirements across clinical trialsDevelop and revise statistical programming procedures or instructionsAssist in compiling technical documents for internal and external audits; Other duties assigned by Leadership

What you'll need (Required):

Bachelor's Degree in fields of Statistics, Mathematics, Computer Science or related field and 10 years previous experience in statistical analysis Required Master's Degree or equivalent with 8 years working in a regulated industry Preferred

What else we look for (Preferred):

Proven successful project management leadership skillsProven expertise in SAS and Windows operating systems required; experience using other software packages (e.g., R, S-Plus) preferredProven 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 skills with ability to drive achievement of objectivesKeeps abreast of new developments in statistics and regulatory guidanceExpert understanding of clinical trial and statistical programming procedures while addressing issues with impact beyond own team based on knowledge of related disciplinesDemonstrated track record in people managementExpert understanding and knowledge relevant to statistical programmingExpert 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 skillsDemonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relationsExperience in facilitating change, including collaboration with management and executive stakeholderStrict 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 participating and presenting at meetings, including with external representativesFrequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project teamParticipate and present at meetings with internal and external representativesAdhere 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 (CA), the base pay range for this position is $148,000 to $210,000 (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.