Sr. Statistical Programmer

Job Description
Responsibilities:

• 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 and Education:

• 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

Salary Range:

94800 - 123300

About Us
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

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 in Aliso Viejo, California with additional locations in San Clemente, California, 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.