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Senior Statistical Programmer

2 months ago

Olympia, Washington, United States Edwards Lifesciences Full time
Transform Patient Lives with Edwards Lifesciences

Imagine how your expertise can change a patient's life. Our Clinical Affairs team generates extensive clinical evidence to demonstrate the effectiveness and safety of our innovations. As a Senior Statistical Programmer, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need.

Key Responsibilities:
  • Develop, test, validate, document, maintain, and execute programs in SAS, serving as lead programmer.
  • 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.
  • Lead in programming analysis datasets.
  • Provide programming expertise on ad hoc data requests in collaboration with project statisticians.
  • Develop program specifications and design documents in partnership with project statisticians.
  • 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, databases, and perform edit checks.
  • Partner with clinical data management teams to ensure databases are defined consistently across clinical trials.
  • Participate in the development of procedures, such as SOP development and standardization of output.
  • Assist in compiling technical documents for internal and external audits.
Requirements:
  • Bachelor's Degree in Statistics, Mathematics, Computer Science, or a related field, with 6 years of experience in statistical analysis.
  • Master's Degree or equivalent in Statistics, Mathematics, Computer Science, or a related field, with 5 years of experience in statistical analysis.
  • Ph.D. or equivalent in Statistics, Mathematics, Computer Science, or a related field, with 2 years of experience in statistical analysis.
Preferred Qualifications:
  • 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, with experience using other software packages, such as R, S-Plus.
  • Extensive understanding and knowledge of regulatory guidelines, such as GCP, ICH, FDA, and ISO, relevant to pharmaceutical/medical device research settings.
  • 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.
  • Ability to work in a team environment, including serving as a consultant to management.
  • Ability to interact with suppliers, vendors, and/or customers.