Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring. They are seeking a Senior Analyst in Statistical Programming to join their Clinical Affairs team, where you will drive the evidence needed to optimize patient outcomes through data analysis and collaboration with various stakeholders.
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
Qualification
Required
Bachelor's Degree in Statistics, Mathematics, Computer Science or related field with 4 years of previous statistical programming experience (e.g. SAS) Required
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
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
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of our employees and their families
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
