Edwards Lifesciences Staff, Statistical Programmer - Transcatheter Heart Valve in Irvine, California
This is a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease.
The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.
You will develop, test, validate, document, maintain and execute programs in SAS, and serve as lead programmer. You will take primary role in review and validation of SAS programs created by more junior-level programmers. In addition, will ensure that all appropriate documentation is appropriately filled out and approved.
Provide programming expertise on one or more clinical trials in programming, documentation, validation and review of summary tables, listings, and figures (TLFs) for inclusion in clinical reports or presentations in collaboration with project statistician
Lead in programming SDTM and ADaMs or analysis dataset (ADS) as a study lead programmer
Deliver expertise on programming ad hoc data requests with cross-collaboration with team members
Develop program specifications for SDTM and ADaMs or ADS and design documents in partnership with project team
Ensure programming code and process meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review
Mentor, coach, and provide guidance to junior-level programmers
Collaborate with Clinical Data Management (CDM) team to review draft Case Report Forms (CRFs), perform UAT test and create edit check report
Partner with CDM team to ensure that the databases is defined consistency across clinical trials and all the parameters needed for analysis per protocol are properly collected in the CRFs
Participate and develop procedures (e.g., SOP development and TLF standardization)
Assist in compiling technical documents for internal and external audits
Other duties assigned by Leadership
Bachelor's Degree in in Biostatistics, Statistics, Mathematics, Computer Science or related field and a minimum of 6 years’ experience in statistical analysis is required (Master’s degree requires 5 years’ experience; PhD requires 2 years’ experience)
Expertise in SAS and Windows operating systems required and proficient in R or Python is preferred
Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
Strong expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
Keeps a strong pulse on new developments in statistics and regulatory guidance
Experience using other programming software packages (e.g., R/R Shiny or Python)
Excellent problem-solving, interpersonal, analytical and critical thinking skills
Strong leadership skills and ability to inspire change
Ability to provide training and mentorship to lower-level employees
Experience in facilitating change, including collaboration with management and executive stakeholders
Strict attention to detail
Ability to lead opposing priorities in a fast-paced environment
Ability to work in a team environment, including serving as consultant to management
Experience in interacting with suppliers, vendors and/or customers
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 15,000 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.