Senior Principal, Statistical Programming

2 weeks ago

Trenton, United States Edwards Lifesciences Full time

Imagine how your ideas and expertise can change a patients 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, youll 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 patients unmet clinical needs. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How youll 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 multiple 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 in multiple clinical trials

  • Provide programming expertise on complex ad hoc data requests in collaboration with project statistician

  • Lead a team of programmers in the development of program specifications and design documents in partnership with project statistician.

  • Collaborate with management to develop or improve procedures and standards

  • Lead a team of programmers in collaboration with cross-functional teams to ensure that database and external data source when applicable meet analysis requirements across clinical trials

  • Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review


What you'll need (Required):

  • Bachelor's Degree in Statistics Mathematics, or Computer Science with 8 years of previous experience in Statistical Analysis

  • Masters Degree or equivalent in Statistics Mathematics or Computer Science with 7 years of previous experience required

  • PHD or equivalent in Statistics Mathematics or Computer Science with 4 years 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 with ability to drive achievement of objectives

  • Keeps abreast of new developments in statistics and regulatory guidance

  • Expert 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)

  • Expert 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 participating and presenting at meetings, including with external representatives

  • Ability to provide guidance to others on area of expertise


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.

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 $145,000 to $205,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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.

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