Glaukos
Statistical Programmer II - Works Onsite in Aliso Viejo, CA
Glaukos, Aliso Viejo, California, United States, 92656
What You’ll Do:
The Statistical Programmer II will work onsite in our corporate headquarters in Aliso Viejo, CA. The Statistical Programmer II generates datasets, tables, listings and graphs to support statistical analyses of data for clinical studies, regulatory submissions and publications. This position requires a basic 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 interactwithStatisticians and other clinical team members to ensure programming requirements are understood.
i.e . Following SAPs, develop specifications and execute derivation algorithms for analysis dataset production.
i.e . Following the SDTM Implementation Guide and written specifications, create programs to produce CDISC-compliant SDTM and ADaM datasets.
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. Assist in validating SAS programs, macros, datasets, and TFL output generated by other Programmers. Other duties as assigned.
How You’ll Get There:
3+ years of experience required with BA/BS Degree, 2+ years of experience with Master's Degree
High proficiency in SAS programming
Experience working with CDISC SDTM and/or ADaM compliant data sets
Knowledge of statistics and the drug development process
Knowledge of FDA/ICH guidelines and industry/technology standard practices
Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
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.
Great compensation and benefits!
This is not a remote role and we are willing to assist with relocation!
#J-18808-Ljbffr
Review key study documents produced by other functions (protocols, statistical analysis plans [SAPs], TFL shells, case report forms) and interactwithStatisticians and other clinical team members to ensure programming requirements are understood.
i.e . Following SAPs, develop specifications and execute derivation algorithms for analysis dataset production.
i.e . Following the SDTM Implementation Guide and written specifications, create programs to produce CDISC-compliant SDTM and ADaM datasets.
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. Assist in validating SAS programs, macros, datasets, and TFL output generated by other Programmers. Other duties as assigned.
How You’ll Get There:
3+ years of experience required with BA/BS Degree, 2+ years of experience with Master's Degree
High proficiency in SAS programming
Experience working with CDISC SDTM and/or ADaM compliant data sets
Knowledge of statistics and the drug development process
Knowledge of FDA/ICH guidelines and industry/technology standard practices
Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
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.
Great compensation and benefits!
This is not a remote role and we are willing to assist with relocation!
#J-18808-Ljbffr