Hiring company: Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. For more than 50 years, we have established a remarkable track record around that innovation: Work that enables clinicians around the world to enhance and save lives.
This is an outstanding and unique opportunity for a Statistical Programmer to join an early-stage product development group within Edwards called Transcatheter Mitral & Tricuspid Therapies (TMTT)! TMTT is passionate about developing solutions for patients suffering from structural heart disease. This is a fast-paced dynamic, and diverse 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.
In this role, you will develop, test, validate, document, maintain and execute programs in SAS for clinical trials.
This position can be remote from within the United States but will require at least one trip per quarter to Edward’s global HQ in Irvine for training and team meetings.
Responsibilities:
Develop or modify analysis datasets for inclusion in clinical reports or presentations; Create programs for summary output (tables, listings, or graphs) 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 analysis in response to data requests in collaboration with designated statistician
Basic Qualifications:
Bachelor's Degree in STEM
3+ years of experience in statistical analysis within a clinical setting
Expertise in SAS and Windows operating systems
Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
Ability to travel at least once per quarter
Preferred Qualifications:
Master’s Degree
Excellent written and verbal communication skills and interpersonal relationship skills including relationship management skills
Strong expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
Keeps a strong pulse on new developments in statistics and regulatory guidance
Experience using other software packages (e.g., R, S-Plus)
Excellent problem-solving, interpersonal, analytical and critical thinking skills
Strict attention to detail
Ability to work in a team environment, including serving as consultant to management
Experience in interacting with suppliers, vendors and/or customers
For Colorado Residents Only:
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.
The base pay range for this position is $91,000 to $107,000.
Additional information can be found through the link below:
https://www.edwards.com/careers/benefits
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.