• Biometrics & Information Sciences (B&I) drives good design to generate data needed for quality decision making. B&I’s goal is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.
• Programming is the department that oversees and delivers the programming aspects of clinical drug development, manages and maintains the end-to-end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure.
• As a member of B&I Programming, collaborates with the Programming Leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project, including but not limited to the following:
- Data submission strategy (e.g., managing legacy data, pooling data)
- Responses to regulatory agency queries
- Tables Figures and Listings (TFLs)
- Development Safety Update Reports (DSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Investigators brochures (IBs)
- Office of Scientific Investigations (OSI) data sets and listings
- Regulatory and/or Payer submission related analysis data sets and/or TFLs
- Associated quality and process documentation as per applicable business processes
- Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets
- Pharmacokinetics/pharmacodynamics data preparation and analysis
- Manipulating and analyzing adjudicated data
- Data preparation and analysis for Global Medical Affairs work
- Clinical Trial Transparency deliverables (data de-identification, results posting files)
- Timely upload of documents to eTMF
• Produce and maintain the technical database standards and Programming Specification documents.
• Contributes to and/or lead aspects of the provision of technical consulting expertise to external partners in relation to the specifications and delivery of the SDTM and ADaM databases by these partners.
• Contributes to and/or lead the development of best practice to improve quality, efficiency and effectiveness.
• Identify opportunities to improve the methodology and provide practical solutions for problems.
• Lead the quality of own and the team's programming work as well as the completeness of applicable quality and process documentation.
• Accountable for good Information Practice on all assigned activities.
• When deployed to a B&I drug project team, operates under the leadership, direction and oversight of a Global Product Programmer (GPP) or her/his delegate.
• Indirect reporting relationship to the Global Product Programmer (GPP)/delegate on assigned drug project teams.
• BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
• Advanced SAS programming knowledge and experience.
• Knowledge of database set-up and report publishing requirements.
• Advanced knowledge of technical and regulatory requirements related to the role.
• Knowledge of CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices.
• Advanced knowledge and experience of clinical drug development or healthcare.
• Develop and deliver training.
Able to demonstrate team working and role leadership skills appropriate to level.
• Advanced verbal, written, communication and collaboration skills.
• Advanced problem solving and conflict resolution.
• Helps drive others to work across global & functional boundaries.
• Travel – willingness and ability to travel domestically and/or internationally.
• Ability to apply programming knowledge and skills to problems and quality focus. Troubleshoots for team.
• Contributes to defining business processes and accurately completes and manages associated documentation.
• Team commitment: prioritize attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.
• Diligence – attention to detail and ability to manage concurrent projects and activities within those projects.
-remote work possibility
-real professional development opportunities
-working for a top company from pharmaceutical sector