Principal, Statistical Programming

2 weeks ago

Irvine, United States Edwards Lifesciences Full time

Job Description
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

**How you will make an impact**:
Develop, test, validate, document, maintain and execute programs in SAS and serve as lead programmer. He/she 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, data listings, and graphs for inclusion in clinical reports or presentations in collaboration with project statistician
Lead in programming analysis datasets
Provide programming expertise on ad hoc data requests in collaboration with project statistician
Develop program specifications and design documents in partnership with project statistician.
Ensure analysis data and programming code 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 CDM to review draft CRFs (Case Report Form), databases and perform edit checks
Partner with clinical data management team to ensure that the databases is defined consistency across clinical trials
Participate in the development of procedures (e.g. SOP development and standardization of output)
Assist in compiling technical documents for internal and external audits; Other duties assigned by Leadership

**What you'll need (required)**:
Bachelor's Degree in Statistics, Mathematics, Computer Science or related field, 6 years experience of previous experience in statistical analysis Required or
Master's Degree or equivalent in Statistics Mathematics, Computer Science or related field, with 5 years experience of previous experience Required or
Ph.D. or equivalent in Statistics Mathematics, Computer Science or related field with 2 years experience of previous experience Required

**What else we look for (preferred)**:
Proven 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 abreast of new developments in statistics and regulatory guidance
Extensive understanding and knowledge relevant to statistical programming
Proven expertise in SAS and Windows operating systems required; experience using other software packages (e.g., R, S-Plus)
Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
Excellent problem-solving, organizational, analytical and critical thinking skills
Strong leadership skills and ability to influence change
Ability to provide training and coaching to lower level employees
Experience in facilitating change, including collaboration with management and executive stakeholders
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 serving as consultant to management
Ability to interact with suppliers, vendors and/or customers
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.

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