Senior Analyst, Statistical Programming – Transcatheter Mitral & Tricuspid Therapies-015039
This is a unique opportunity for a Senior Analyst, Statistical Programmer to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. This is a fast-paced, dynamic team and the individual in this position will play a pivotal role in the development of new therapies and devices, from concept through to human use.
Essential job functions:
Provide programming support in the development of complex analysis datasets, specifications, and summary output (tables, data listings, and graphs) for inclusion in clinical reports or presentations in collaboration with designated statistician.
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 are consistently structured and meet regulatory and company standards.
Perform complex analysis in response to data requests in partnership 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.
Master’s degree in Statistics, Mathematics, Computer Science or related field and 2-3 years of clinical trial experience within the medical device, pharmaceutical, biotech industries or Bachelors in Statistics, Mathematics, Computer Science or related field and 5 years of clinical trial experience within the medical device, pharmaceutical, biotech industries.
Proven expertise in SAS and Windows operating systems required.
Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel.
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 a Pharmaceutical/Medical Device setting.
Strong problem-solving, organizational, analytical and critical thinking skills.
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.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Job Function: Clinical Affairs
Primary Location: USA-USA-California - Irvine