Job Title: Sr. Statistical Programmer Position Description
- Provides statistical programming support for the implementation of data models and the reporting of clinical trials.
- Develops and performs quality control on analysis datasets and tables, figures and listings via an appropriate statistical analysis system (i.e. SAS ® ).
- Provides input to the statistical analysis plan, table shells, data integration plans, and publications.
- Liaises with other departments to properly implement data models (e.g. SDTM/ADaM).
- Researches new technologies and techniques to improve efficiency of programming outputs.
- Programs statistical analyses (via analysis datasets, tables, figures, listings, etc.) using an appropriate statistical analysis systems (i.e. SAS ® ).
- Helps ensure the accuracy and consistency of data flow from case report forms (CRFs) and database definitions, through to and specifications for analysis datasets.
- Performs quality review of analysis dataset and TFL programs developed by other programmers and biostatisticians.
- Verifies that all statistical analysis system programs and associated documentation are archived following the creation of final output.
- Assists in the development of new processes and makes sure all process improvements are implemented.
- Reviews and provides feedback regarding statistical analyses plans.
- Collaborates with other team members to develop quality reports, publications, and regulatory submissions.
- Helps maintain libraries of documented and validated programs, macros, and procedures which can be reused to aid in department efficiency.
- Serves as a mentor to other programmers.
- Demonstrates a working knowledge of industry metadata submission requirements.
- Demonstrates advanced knowledge of computer programming, statistical analysis systems (SAS), and other procedural languages.
- Shows solid understanding biometrics procedures, workflows, and software systems.
- Displays ability to manage extremely large datasets for statistical analysis and mathematical model creation.
- Exhibits excellent written and oral communication skills.
- Demonstrates a strong knowledge and understanding of analysis data structure standards (ADaM) and a good understanding of conversion data structure standards (SDTM)
- Applies leadership skills in the coordination of analysis and reporting activities for statistical programming projects.
- Bachelor's degree in a quantitative or scientific field
- 5 years of statistical programming experience.
- Experience performing statistical analyses on data required.
- SDTM and/or ADaM experience is required, specifically creating/authoring specifications for SDTM and/or ADaM datasets.
- Experience with TFLs (tables, figures, and listings) or TLGs (tables, listings, and graphs) is required.
- Experience leading project teams is required.
- Experience within pharma or CRO experience required. CRO experience preferred.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.