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/ $115000 - $120750 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. 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.

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.

Interested Applicants Email Resume:

Glaukos Corporation

Attn: K. Sauer/ Ref SPII