Glaukos Corporation
Overview
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 Responsibilities
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 CDISC SDTM and ADaM. Create programs that generate tables, figures, and listings (TFLs) in accordance with the SAP and TFL shells using SAS technologies (Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, SAS/SQL) to visualize, interpret, and report data findings. Maintain clear and accurate documentation of programming activities to ensure reproducibility and facilitate regulatory submissions. Follow SAPs (Statistical Analysis Plans) to develop specifications and implement complex derivation algorithms in SAS to produce analysis datasets and ensure accuracy for statistical models; perform ANCOVA and generalized linear modeling to analyze safety, efficacy, and device performance in clinical trials. Follow the SDTM Implementation Guide and written specifications to create, review, and validate SDTM and ADaM datasets for traceability and regulatory compliance with CDISC standards. Review and analyze key study documents (protocols, SAPs, TFL shells, case report forms) and collaborate with cross-functional teams 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. 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. Qualifications
Masters 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. 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.
Good verbal and written communication skills.
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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 Responsibilities
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 CDISC SDTM and ADaM. Create programs that generate tables, figures, and listings (TFLs) in accordance with the SAP and TFL shells using SAS technologies (Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, SAS/SQL) to visualize, interpret, and report data findings. Maintain clear and accurate documentation of programming activities to ensure reproducibility and facilitate regulatory submissions. Follow SAPs (Statistical Analysis Plans) to develop specifications and implement complex derivation algorithms in SAS to produce analysis datasets and ensure accuracy for statistical models; perform ANCOVA and generalized linear modeling to analyze safety, efficacy, and device performance in clinical trials. Follow the SDTM Implementation Guide and written specifications to create, review, and validate SDTM and ADaM datasets for traceability and regulatory compliance with CDISC standards. Review and analyze key study documents (protocols, SAPs, TFL shells, case report forms) and collaborate with cross-functional teams 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. 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. Qualifications
Masters 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. 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.
Good verbal and written communication skills.
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