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
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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