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Principal, Statistical Programming

Company: Edwards Lifesciences Corporation
Location: Irvine
Posted on: May 24, 2023

Job Description:

This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.

As a Principal, Statistical Programming, 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.

This role can be remote, hybrid or onsite. For hybrid or remote employees, this will be include regular trips to the Irvine campus.

Key Responsibilities including but not limited to:

  • 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

    Minimum Requirements:
    • Bachelor's Degree in in Statistics, Mathematics, Computer Science or related field, 6 years experience of previous experience in statistical analysis OR
    • Master's Degree or equivalent in in Statistics Mathematics, Computer Science or related field and 5 years experience OR
    • Ph.D. or equivalent in in Statistics Mathematics, Computer Science or related field and 2 years experience
    • Proven expertise in SAS and Windows operating systems required; experience using other software packages (e.g., R, S-Plus)
    • Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel

      General Skills:
      • 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
      • 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
      • 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 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.

        The base pay range for this position is $123,000 to $174,000 (highly experienced).

        The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).

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

        COVID Vaccination Requirement

        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, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

Keywords: Edwards Lifesciences Corporation, Irvine , Principal, Statistical Programming, Other , Irvine, California

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