Provides technical expertise for the conduct of clinical trials and acts as an internal subject matter expert in specific areas
Works independently to support various programming activities related to the analysis and reporting of clinical study data
Can fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required
Monitors quality, timelines, resource allocation, and productivity in relation to budgets
Provides technical support and expert advice to internal and external sponsors
Recognized as a subject matter expert and expected to mentor and lead global teams
Supports programming activities related to the analysis and reporting of clinical study data and ensures adherence to SOPs and regulations
Requirements
Proven record of successfully leading teams in a statistical programming environment with sound Clinical / SAS Programming experience (minimum +3.5 years related experience is essential to be considered for a Senior level. 5yrs + with Lead Programming experience is required for Principal level.)
Competent in written and oral English
Excellent communication skills
Excellent analytical skills
Advanced knowledge of SAS programming techniques
Extensive knowledge and understanding of the programming and reporting process
Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11
Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated
Ability to learn new systems and function in an evolving technical environment
Strong project management skills
Strong organizational skills, ability to manage competing priorities, and flexibility to change
Attention to detail
Ability to successfully lead and mentor a global team
Work effectively in a quality-focused environment
Excellent time management in order to meet daily metrics or team objectives
Show commitment to and perform consistently high quality work
Strong business/operational skills that include customer focus, commitment to quality management, and problem solving
Demonstrate commitment to refine quality processes
Good presentation skills
Ability to negotiate and influence in order to achieve results
Good business awareness/business development skills (including financial awareness)
Client-focused approach to work
Educated to degree level in a relevant discipline and/or equivalent work experience