Statistical Programmer
Statistical Programmer at AbbVie supporting clinical trial analysis and reporting: building ADaM datasets and Tables/Listings/Figures in SAS under CDISC standards, validating outputs, consolidating data sources, and preparing regulatory filing documentation alongside statisticians and clinical teams.
- Compensation
- Not disclosed
- Location
- Irvine, CA, us
- Work setup
- Hybrid
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- 0+ years
- Category
- Not specified
- Posted
Skills
Must have
- MS in Statistics, Computer Science or related field with 0+ years relevant experience, OR BS in Statistics, Computer Science or related field with 2+ years relevant experience
- Demonstrated practical understanding of SAS programming or NONMEM concepts and techniques
- Ability to communicate clearly both oral and written
- Develop SAS programs for ADaM data sets following CDISC standards and validate ADaM datasets
- Develop SAS programs for creation and validation of Tables, Listings and Figures
Nice to have
- Create documentation for regulatory filings including reviewers guides and data definition documents
- Consolidate heterogeneous data sources into analysis-ready data sets within a quality control process
- Perform exploratory data analyses and produce dynamic and static data visualizations
Full description
The Statistical Programmer is an integral project team member in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data under the direction and oversight of a Senior Statistical Analyst. The Statistical Programmer interfaces with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.)
Responsibilities
- The Statistical Programmer will:
- Create documentation for regulatory filings including reviewers guides and data definition documents.
- Participate in the development of standard SAS Macros.
- The Programmer will:
- Consolidate heterogeneous data sources (e.g. clinical study databases, external databases, real-world data) to prepare analysis-ready data sets within a defined quality control process supporting a particular study.
- Perform exploratory data analyses and visualizations in interaction with the clinical pharmacologist or pharmacometrician.
- Produce dynamic and static data visualizations to communicate quantitative analyses.
- Develop SAS programs for the creation of ADaM data sets following CDISC standards
- Develop SAS programs for the creation of Tables, Listings and Figures.
- Validation of ADaM data sets.
- Validation of Tables, Listings and Figures.
- Create specifications for the structure of ADaM data sets for individual studies.
- MS in Statistics, Computer Science or a related field with 0+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 2+ years of relevant experience.
- Demonstrated practical understanding of SAS programming or NONMEM concepts and techniques.
- Ability to communicate clearly both oral and written.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.