Job Description
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for Statistical Programmer II to join our A-team (hybrid*). As a Statistical Programmer II (SP2) you will be supporting the programming of clinical data analysis activities of Allucent. This position is able to support multiple studies, and programs simple to moderate datasets and outputs using SAS®, while beginning to control and monitor specific activities within the project team.
In this role your key tasks will include:
- Supports programming of clinical data analyses.
- Create and execute SAS® programs according to project specifications for simple outputs including, but not limited to, data listings.
- Implements statistical analysis plans.
- Understand and comply with all industry-relevant regulatory requirements.
- Employ standardized programs where applicable.
- Validate work of other programmer(s).
- Ensure the maintenance of programming documentation (e.g. description of programs and validation).
- Interacts with statisticians, data management personnel, and project leaders.
- Analyzes and evaluates clinical data, recognizes inconsistencies and initiates resolution of data problems.
- Create and execute SAS® programs according to project specifications for mapped datasets, including SDTM.
- Support projects and execute statistical programming activities according to timelines and milestones promptly without sacrificing quality.
- Generate aCRF, Define XML and other study documents.
- Familiar with Pinnacle 21, managing delivery QC checklists, large study batching, checking logs and other project management processes necessary to lead a study.
- Familiar with CDISC standards and writing SDTM specs for studies with simple complexity.
- Create and/or review SDTM and/or mapped data specifications of simple complexity.
- Actively participate in staff learning & development within the company.
- Ability to provide mentoring to junior staff.
- Understands and completes all SOPs within the Quality Management System on time.
- Assure good communication and professionalism in relationships with (future) clients.
- Contribute and take part in client evaluations, visits and bid defences.
