Statistical Programmer II na Glaukos Corporation
Glaukos Corporation · Aliso Viejo, Estados Unidos Da América · Onsite
- Professional
- Escritório em Aliso Viejo
Job Title: Statistical Programmer II
Employer: Glaukos Corporation
Location: One Glaukos Way, Aliso Viejo, CA 92656
Hours/Salary: Full-time 40 hours per week/ $115,000 - $120,750 per year
Job Duties:
Develop and implement analytics applications to transform raw data into datasets, tables, listings and graphs to support statistical analyses of data for clinical studies, regulatory submissions and publications for an ophthalmic pharmaceutical and medical technology company. Apply knowledge of FDA/ICH guidelines and current industry standards, including Clinical Data Interchange Standards Consortium [CDISC] Study Data Tabulation Model [SDTM] and Analysis Data Model [ADaM]. Create programs that generate tables, figures, and listings, [TFLs] in accordance with the SAP and TFL shells using SAS statistical graphics technology (Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, and SAS/SQL) to visualize, interpret, and report data findings. Maintain clear and accurate documentation of programming activities to ensure reproducibility and facilitate regulatory submissions. Following SAPs [Statistical Analysis Plans], use SAS/Stat to develop specifications and implement complex derivation algorithms in order to produce analysis datasets and ensure accuracy in analysis datasets used for statistical models; perform ANCOVA (Analysis of Covariance), and generalized linear modeling to analyze safety, efficacy, and device performance in clinical trials. Following the SDTM Implementation Guide and written specifications, create, review, and validate SDTM and ADaM datasets to ensure traceability and compliance with regulatory guidelines and CDISC Standards. Review and analyze key study documents produced by other functions (protocols, statistical analysis plans [SAPs], TFL shells, case report forms) and collaborate with cross-functional teams (statisticians, data managers, and project leads) to ensure accurate implementation of study requirements. Contribute to the development of standard macros and reusable programs to improve efficiency and consistency across projects and assist in validating SAS programs, macros, datasets, and TFL output generated by other Programmers. Perform quality control (QC) and validation of TLFs to ensure they meet internal and external standards. Test, validate, and reformulate models to ensure accurate prediction of outcomes of interest.
Job Requirements:
1. Master’s degree in Business Analytics, Statistics, Data Science, or Computer Science, plus 2 years of experience in the Job offered or as a Statistical Programmer or Data Scientist in the medical device and/or pharmaceutical industry.
2. Must include experience with the following:
- SAS programming (Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, and SAS/SQL).
- CDISC SDTM and/or ADaM compliant data sets.
- Development and validation of TLFs.
- FDA/ICH guidelines and industry/technology standard practices.
3. Good verbal and written communication skills.
Company
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.
