Description:
As an experienced Statistical SAS Programmer in our Flexible Solutions (FSP) business unit, you are central to the success of complex oncology trials. You will be dedicated to a single sponsor, supporting a renowned, innovative, and global top pharmaceutical company, while working alongside our dedicated, talented and growing team of experienced statistical programmers working with this sponsor.
Main Job Tasks and Responsibilities:
- Leads and directs the full scope of project delivery and/or leads a technical project within the TA/Drug Project/study/function.
- Leads Implementation of statistical programming aspects of the protocol or clinical development program.
- Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverable and/or technical subject matter expert for aspect(s) of the TA, Project, or function Leads or contribute to cross-functional administrative or process improvement initiative(s)
- Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function. Drives standards development and implementation.
- Manages and escalates risk in complicated or novel situations within their study and/or projects.
- Provides Programming expertise to the team.
- Provides tactical input and/or drives ideas and improvements.
- Contributes to the function by supporting recruiting and/or providing training and mentorship.
- Identifies opportunities to improve methodology and provides practical solutions for problems.
- Influences stakeholders by providing subject matter expertise on programming-related items.
- Ensures compliance with standards and automation usage.
- Employs all project management practices in managing drug or technical projects.
- Provides input to capacity management for all projects in scope.
- Maintains expertise in the latest industry and regulatory requirements to stay current.
Requirements:
- 6 years + of SAS programming experience in a clinical trial environment
- Experience with CDISC (ADaM and/or SDTM), CDT and submissions experience
- Experience with ISS (Summary of Safety) and ISE (Summary of Efficacy) preferred
- Must have experience with Oncology studies
- Experience creating custom macros