Senior Analyst, Statistical Programming THV

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.

Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.

How you’ll make an impact:

• Plan the execution of programs in statistical programming languages within project.
• Develop complex analysis datasets, specifications, and summary output (tables, listings, or graphs) for inclusion in clinical reports or presentations; Create complex programs that meet regulatory and company standards to permit efficient programming, reporting, and review, utilizing statistical programming languages (e.g SAS)
• Review and validate statistical programs and ensure that all appropriate program validation documentation to meet regulatory and company standards are consistently structured to permit efficient programming, reporting, and review
• Perform complex analysis in response to data requests in collaboration with designated statistician
• Collaborate with CDM (Clinical Data Management) and designated statistician to review draft CRFs (Case Report Forms), database specifications, and perform edit checks

What you'll need (Required):
Bachelor's Degree in Statistics, Mathematics, Computer Science or related field, with 4 years of previous statistical programming experience (e.g. SAS) Required or
Master's Degree or equivalent in Statistics, Mathematics, Computer Science or related field, with 2 years of previous statistical programming experience (e.g. SAS) Required

What else we look for (Preferred):

• Proven expertise in interfacing MS Office Suite with SAS
• Good written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
• Full understanding and knowledge relevant to statistical programming
• Full understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device setting
• Strong problem-solving, organizational, analytical and critical thinking skills
• Experience working in clinical trials within a pharmaceutical/medical device industry
• Good leadership skills and ability to influence change
• 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 inter-departmental teams and key contact representing the organization on projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• 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 $116,000 to $164,000 (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.