Statistical Programmer II - Works Onsite in Aliso Viejo, CA
About The Position
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 interact with Statisticians 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
Requirements
- 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
Nice To Haves
- Master's degree is preferred.
Responsibilities
- Generate datasets, tables, listings and graphs to support statistical analyses of data for clinical studies, regulatory submissions and publications
- 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
- Following SAPs, develop specifications and execute derivation algorithms for analysis dataset production
- 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
Benefits
- Great compensation and benefits!
- This is not a remote role and we are willing to assist with relocation!
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Miscellaneous Manufacturing
Number of Employees
1,001-5,000 employees
