Sr. Statistical Programmer at Glaukos Corporation in San Clemente, California

Job Description:

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world’s leading causes of blindness. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company’s second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA. In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. The company was founded in 1998 and is based in San Clemente, California.

How will you make an impact?

The Senior Statistical Programmer, based in San Clemente, CA will be responsible for generating tables, listings and graphs to support statistical analyses of data for clinical studies, regulatory submissions and publications. This position requires a good understanding and ability to provide datasets using current industry standards including Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).

What will you do?

• 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.


• Following SAPs, develop specifications and execute derivation algorithms for analysis dataset production.


• Following the SDTM Implementation Guide and written specifications, create programs to produce CDISC-compliant SDTM and ADaM datasets anddefine.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.


• Other duties as assigned.

How will you get here?

• Experience working in Pharmaceutical/ Biotechnology/CRO industry as a Statistical SAS Programmer generating TFLs is required (>= 4 years with MS degree; >=6 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.


• 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


• Solid verbal and written communication skills

Education:

• Bachelor's /Master's Degree in Statistics, Mathematics, Computer Science, or other related discipline is required; Master's degree is preferred

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.

Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we’re a rapidly growing company with a dynamic, fast-paced culture, individual employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.

We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous paid time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Check out our profile on The Muse to get an inside look at our company culture. Glaukos has been named one of the Top Workplaces by the Orange County Register for the past 3 years!

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.