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Edwards Lifesciences Principal SAS Programmer, (Remote) AT in Washington, District Of Columbia

Principal SAS Programmer, (Remote) Advance Technologies

An exciting opportunity with the Advanced Technologies team, currently involved in new cutting-edge products and processes. In this innovative team you will be responsible to lead the SAS statistical programming to leverage applied research and design to new medical device product development.

The Principal SAS Programmer develop, test, validate, document, maintain and execute programs in SAS and serve as lead programmer. He/she will take a 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.

Responsibilities include, 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 database provides 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

Minimum Requirements:

  • Bachelor's Degree in in Statistics, Mathematics, Computer Science or related field and 6 years previous experience in statistical analysis required OR

  • Master's Degree or equivalent in Statistics, Mathematics, Computer Science or related field and 5 years previous experience required OR

  • Ph.D. or equivalent in Statistics, Mathematics, Computer Science or related field and 2 years previous experience Required

Additional Talents and General Expectations:

  • 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

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.

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