Our client is a global pharmaceutical brand who are expanding their programming and statistical teams. They are currently looking for senior level programmers who will be engaged on inital 12 month contracts on a fully remote basis.
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.
Key requirements include:
Collaborate 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)
- Oncology experience essential, preferably study lead experience
- Responses to regulatory agency queries
- Tables Figures and Listings (TFLs)
- Development Safety Update Reports (DSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- 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
Essential experience/skills:
• 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.
