Sr Analyst, Statistical Programming

Edwards Lifesciences • Irvine, CA

1d • $119,000 - $168,000 • Onsite

About The Position

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. 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: 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 This role is an on-site position at our Edwards Life sciences corporate headquarters in Irvine, California

Requirements

• Bachelor's Degree in Statistics, Mathematics, Computer Science or related field , 4 years experience previous statistical programming experience (e.g. SAS) Required
• Master's Degree or equivalent in Statistics, Mathematics, Computer Science or related field , 2 years experience previous statistical programming experience (e.g. SAS) Required

Nice To Haves

• Skills of leveraging emerging AI and automation capabilities to enhance efficiency, quality, and scalability of statistical programming workflows.
• 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.

Responsibilities

• 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.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior