Our client is a global pharmaceutical brand who are expanding their programming and statistical teams. They are currently looking for principal or 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.