Sr Analyst, Statistical Programming at Edwards Lifesciences

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Sr Analyst, Statistical Programming Edwards Lifesciences. . 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.. . 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.. . 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. Other duties assigned by Leadership. . 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 experience 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 $113,000 to $161,000 (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 complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.. .