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
What you'll need (Required):- Bachelor's Degree in Statistics, Mathematics, Computer Science or related field , 4 years experience previous statistical programming experience (e.g. SAS) Required or
- Master's Degree or equivalent in Statistics, Mathematics, Computer Science or related field , 2 years experience previous statistical programming experience (e.g. SAS) Required
- This role is an on-site position at our Edwards Life sciences corporate headquarters in Irvine, California
What else we look for (Preferred):- 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
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 $119,000 - $168,000 (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.
