Senior Statistical Analyst

Job Description
Key Responsibilities
 
Perform statistical programming activities for all assigned Phase I-IV clinical studies sponsored by AbbVie and its partners.
Perform statistical programming for clinical studies, integrated summaries, and in support of responses to requests from regulatory authorities.
Provide programming and documentation support for multiple studies with high quality.
Utilize experience in SAS and Linux.
Review statistical analysis plans for all assigned studies and integrated summaries in conjunction with program lead and provide comments to study biostatistician.
Utilize knowledge of statistical methodology in clinical trials, FDA regulations and CDISC standards.
Create ADaM data set specifications for all assigned studies and integrated summaries.
Ensure study analysis is consistent with standard templates and specifications.
Contribute to submission support.
Contribute to development of new standard templates.
Participate in development of standard operating procedures and support documents related to Statistical Programming processes.
Support urgent regulatory agency requests.
Participate in a Statistical Programming process improvement initiative.
Manage timelines and ensure good communication with CROs/FSPs and internal programmers.
Oversee programming tasks for a single study.
Project management and conduct high level review of deliverables provided by CRO/FSP to ensure good quality and accuracy.