Support US and/or EU Early Phase statistical programming teams by developing SAS programs for analysis datasets.
Generate Listing and safety summary tables.
Provide project tracking information to the team, address any validation comments and document programming activities.
Work on more advanced, complex SAS requirements, across multiple studies, and act as a subject matter expert within the SAS programming team; mentor and help train other team members from juniors to Programmer II.
The Role:
Lead and manage the assigned programming team's deliverables at the study and program level.
Serve in a client-facing capacity that demonstrates the ability to anticipate client needs and implement innovative solutions.
Facilitate flow of information on study budgets and change order management in a timely and efficient manner.
Set-up and maintain the PDVD according to the procedures for Planning, Executing, Tracking and Documentation of Programming and Validation activities.
Liaise effectively with other ICON functions (e.g., DM, MW), as required during the life of the project.
Monitor programming activities in terms of added value and controlling costs, as required.
Support Business Development activities, including participation in sponsor calls and meetings.
Create and maintain analysis dataset specifications to a high standard of quality and accuracy.
Required:
Oncology Therapeutic area
Prior Phase I or early phase experience
Pharmacokinetic and Pharmacodynamic modeling experience (PK/PD)
Bachelors degree, in a quantitative or scientific discipline, or local equivalent.
Clinical research industry experience (preferably in a CRO)
Prior experience leading a programming team to manage timelines, resources and overall quality in a client-facing capacity
Working knowledge of data structures (e.g., CDISC SDTM, ADaM)
Working knowledge of the development and use of standard programs and macros