Job Description
How will you make an impact?
The Sr. Statistical Programmer II functions as the lead programmer for assigned clinical studies, who coordinates and oversees the statistical programming activities, such as generating SDTM/ADaM datasets and statistical outputs (TLFs), to support statistical analyses in regulatory submissions, post-marketing, and publications.
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.
- Managing/coordinating resources on study basis to ensure high-quality and on-time deliverables of statistical analyses.
- Capable of developing the written specifications based on SDTM/ADaM Implementation Guide and creating programs to produce CDISC-compliant SDTM/ADaM datasets and define.xml files.
- Generate tables, figures, and listings, (TFLs) in accordance with TFL shells to support analyses using Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, or other statistical graphics technology.
- Capable of validating SAS programs, macros, datasets, and TFL output generated by other programmers.
- Ensure consistency across programming methods in similar studies within a project.
- Contribute to requests for proposals for programming services from outsourcing vendors. Provide oversight and monitor progress of vendors working on sponsored studies. Develop or assist in the development of departmental processes and procedures.
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- Experience working in Pharmaceutical/ Biotechnology/CRO industry as a Statistical SAS Programmer generating TFLs is required (>= 6 years with MS degree; >=8 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.
- Experience programming supporting integrated analyses, e.g. ISS, ISE.
- Good 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
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 are empowered with more diverse and enriching challenges that 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 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! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three 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.
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.