Sr. Satistical Programmer Sangart
THIS JOB HAS EXPIRED Description of Duties:
The Senior Statistical Programmer is responsible for the development and maintenance of statistical programming and validation support for clinical study projects as follows:
Creates and maintains the network SAS programming environment, including the directory structure for programs, macros, and program output.
Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
Validate work of other programmer/analysts at CRO or in-house.
Maintain complete and auditable documentation of all programming activities.
Establishes standards for the development and validation of SAS programs to ensure that all programs are in compliance with Sangart Standard Operating Procedures (SOPs) and the Code of Federal Regulations (CFRs).
Review Data Management Plan, Data validation plan and edit check specifications.
Provides assistance to Data Management for optimizing the naming and structure of SAS datasets created from clinical study databases.
Provides input to Data Management for database and Case Report Form (CRF) development.
Manages the transfer and analysis of clinical trial data from Contract Research Organizations (CROs) and Sangart consultants.
Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP).
Develops and maintains Sangart SOPs and Working Instructions for Statistical Programming.
Other duties as assigned by the Director, Biostatistics and Programming.
Experience in the analysis of complex clinical trial data.
Solid knowledge/experience of CDISC standard (SDTM & ADaM).
Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
5 to 8 years of SAS programming experience in the biotech, pharmaceutical, or CRO environment.
BS/MS in Statistics, Math or Scientific Discipline.
Effective organizational skills.
Computer proficiency, e.g., Microsoft Word, Excel, Project, PowerPoint, and Outlook.
Excellent interpersonal skills, effective verbal and written communication and team participation skills.
||6175 Lusk Boulevard |
San Diego, CA 92121
THIS JOB HAS EXPIRED