Statistical Programmer II

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.