• Drive and facilitate the expansion of data presentation standards within GBDS taking primary responsibility for standardizing the presentation of clinical trial results in Tables, Figures and Listings. The role is positioned within the Biomedical Data Stewardship (BMDS) organization and the successful candidate would work alongside other BMDS staff in the development of end-to-end data standards and ensure that TFL requirements are considered in the development of collection standards.
• Lead the Global Standardized Data Presentation Governance Committee
• Lead the continuous improvement of data presentation processes and supporting technology
Responsibilities:
• Ensuring best data presentation practice through leadership of cross-functional Global Standardized Data Presentation Governance Committee
• Maintaining compliance and compatibility with CDISC standards particularly ADaM.
• Contributing to the development and strategy of the GBDS Data Stewardship organization
Key Activities:
• Collaborate cross-functionally and within GBDS Data Stewardship to drive forward compliance with standards, processes and training
• Track key metrics and reporting to GBDS and R&D Senior Management
• Lead, motivate and develop the Global TFL Committee
• Develop and maintain strong working relationships with key stakeholders
Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master's degree & 6 years of directly related experience OR - Bachelor's degree & 8 years of directly related experience OR - Associate's degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience
Preferred Qualifications - Bachelors degree in statistics/ biostatistics, programming, life science, computer science
- 8 years work experience in data management, biostatistics or programming in the Pharmaceutical or Biotech arena
- 3+ years experience in a global organization
- Demonstrated ability to influence decision making
- Development of policies and SOPs
- Experience collaborating on global cross-functional teams
- Knowledge of project management, documentation writing, training, and compliance
- Interest in process improvement methodologies
- Use of software and data applications within drug development
- Appreciation of computer system architecture and hardware
