Principal Statistical Programmer
- Experience Level
- Experienced (non-manager)
Principal Statistical Programmer
Location: South Africa, Europe
At PRA, we don’t make our 17000+ people great. It’s the other way around. As we have grown to a top-5 CRO, we have maintained the feel of a small company, dedicated to collaboration and passion for what we do.
We always have a desire to keep seeking new and better ways to operate. We don’t settle for the same old ways. Our passion for improving patient lives worldwide permeates all that we do. Put simply, we care.
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.
Delivery focused and an innovative leader.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- Bachelor’s degree in a quantitative or scientific field
- Statistical programming experience.
- Experience performing statistical analyses on data required.
- SDTM and ADaM experience is required, specifically creating/authoring specifications for SDTM and 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.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.