The opportunity
The Clinical Programming team is responsible for some critical aspects of Teva’s clinical trials process and related activities. A Technical Team under Clinical Programming will provide us with the best chances to deal with the challenges, the manager of this team (Associate Director level) reports to the Head of Clinical Programming directly.
How you’ll spend your day
The Technical Team will be in charge of the following areas:
1. Clinical trials production systems management and business processes improvement
It is in Clinical Programming’s long term best interest to retain SAS technical expertise in house. As the cloud gradually replaces Teva data center over the next few years and clinical trials processing shifts to the cloud entirely, there will undoubtedly be many new challenges that require innovation and creativity. A proven technical expert grounded in Clinical Programming’s current processes will best serve this role. As time goes by, the team can grow to have additional members who will share the knowledge and responsibilities, thus enhancing technical stability for Clinical Programming.
2. Development of new technologies and tools
Many pharmaceutical companies are exploring, and adopting, new technologies and tools that fall outside of the traditional SAS tools in their attempt to speed up new drug development and improve patient safety. Inside Clinical Programming, multiple initiatives are ongoing to develop similar tools to improve our processes. These include using Python to create aCRF/Reduction/Reporting Dashboard, using R Shiny to develop interactive web apps, using Visual Basic to enhance Microsoft Office documents, and leveraging Adobe Pro for PDF bookmarks, etc. As these and future projects grow and mature, they will benefit greatly from the coordination and direction of a dedicated Technical Team, with the potential for significant synergy. Some projects may be undertaken by the Technical Team directly.
3. Cross-functional support of other teams
Clinical Programming has been providing various support to other teams. For example, Clinical Programming has an automated process to transfer any new files in the Final TLGs folder to Medical Writing and notify them by email too. Clinical Programming also provides extensive SAS and database programming support to the RWE team in their Microsoft Azure Databricks environment. These and other support activities will continue under the Technical Team.
4. Vision for future growth
The pharmaceutical industry as a whole is scrutinizing the current practices and processes of new drug development and trying to figure out a way to bring in revolutionary technologies and processes that have greatly transformed some other industries or fields. Artificial intelligence and machine learning hold tremendous promise for clinical trials and other aspects of new drug development, but how and where to apply them successfully in this highly regulated environment is the key. Teva already has an AAAI team that is pioneering these technologies, and the Technical Team will engage with AAAI to bring AI and ML into the clinical trials process as appropriate. Similarly, insights from HEOR / RWE research can inspire ideas for new drugs or new protocols. The Technical Team can work with the RWE team to explore areas of cooperation in support of ongoing clinical trials.
