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Sr. Statistical Programmer

Sr. Statistical Programmer

Glaukos CorporationUnited States
30+ days ago
Job type
  • Full-time
Job description

Review key study documents produced by other functions (protocols, statistical analysis plans [SAPs], TFL shells, case report forms) and interact with Statisticians and other clinical team members to ensure programming requirements are understood.

  • Follow SAPs, develop specifications and execute derivation algorithms for
  • analysis dataset production.
  • Follow the SDTM and ADaM Implementation Guide to develop specifications, create programs to produce CDISC-compliant SDTM and ADaM datasets and define.xml files.
  • Generate tables, figures, and listings, (TFLs) in accordance with the SAP and TFL shells to support analyses using Base SAS, SAS Macro, SAS / STAT,
  • SAS / GRAPH, or other statistical graphics technology.
  • Create and maintain integrated analysis datasets including closed and ongoing studies.
  • Validate SAS programs, macros, datasets, and TFL output generated by other Programmers.
  • Develop or assist in the development of departmental processes and procedures.
  • Experience working in Pharmaceutical / Biotechnology / CRO industry as a
  • Statistical Programmer is required (>

3 years with MS degree; >

5 years with BS degree).

  • High proficiency in SAS programming and Macro development
  • Experience working with CDISC SDTM and ADaM compliant data sets
  • Experience with regulatory submissions and creating Define.XML.
  • Knowledge of statistics and the drug development process
  • In-depth knowledge of FDA / ICH guidelines and industry / technology standard practices
  • Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
  • Capable of critical thinking and independently identifying issues in existing programs
  • Solid verbal and written communication skills
  • Bachelor's / Master's Degree in Statistics, Mathematics, Computer Science, or other related discipline is required; Master's degree is preferred
  • Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

    Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device—the iStent®—in the United States, followed by our next-generation iStent

    inject

    device in September 2018 and iStent

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    W in September 2020.

    In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.

    Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.

    Glaukos Corporation

    is an Equal Opportunity / Affirmative Action Employer.

    All qualified applicants will receive consideration for employment   without regard to race, color, religion, sex including sexual orientation and gender   identity, national origin, disability, protected Veteran Status, or any other   characteristic protected by applicable federal, state, or local law.

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    Statistical Programmer • United States