Sr. Statistical Programmer at Glaukos Corporation

, , United States -

Full Time

Start Date

Immediate

Expiry Date

21 Dec, 25

Salary

0.0

Posted On

22 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SAS Programming, Macro Development, CDISC SDTM, ADaM, Regulatory Submissions, Define.XML, Statistics, Drug Development Process, FDA Guidelines, ICH Guidelines, Statistical Terminology, Clinical Tests, Medical Terminology, Protocol Designs, Critical Thinking, Communication Skills

Industry

Medical Equipment Manufacturing

Description

What You’ll Do: The Senior Statistical Programmer generates tables, listings and graphs to support statistical analyses of data for clinical studies, regulatory submissions and publications. This position requires a good understanding and ability to provide datasets using current industry standards including Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM). 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. Follow SAPs, develop specifications and execute derivation algorithms for analysis dataset production. Follow the SDTM and ADaM Implementation Guide to develop specifications, create programs to produce CDISC-compliant SDTM and ADaM datasets and define.xml files. Generate tables, figures, and listings, (TFLs) in accordance with the SAP and TFL shells to support analyses using Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, or other statistical graphics technology. Create and maintain integrated analysis datasets including closed and ongoing studies. Validate SAS programs, macros, datasets, and TFL output generated by other Programmers. Develop or assist in the development of departmental processes and procedures. Other duties as assigned. How You’ll Get There: Experience working in Pharmaceutical/ Biotechnology/CRO industry as a Statistical Programmer is required (>= 3 years with MS degree; >=5 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 and creating Define.XML. 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 Capable of critical thinking and independently identifying issues in existing programs Solid verbal and written communication skills Bachelor's /Master's Degree in Statistics, Mathematics, Computer Science, or other related discipline is required; Master's degree is preferred

Responsibilities

The Senior Statistical Programmer generates tables, listings, and graphs to support statistical analyses of data for clinical studies. This includes developing specifications and executing derivation algorithms for analysis dataset production.