The Principal Programmer – Data Science Systems will be primarily responsible for, but not limited to, establishing open source programming methods and other emerging industry technologies within the Quantitative Sciences organization (QS). Additionally, this person will use his/her strong technical, organizational and project management skills to provide direction and leadership to internal and external collaborators supporting the development, implementation and support of software tools and technologies within QS. They will work with Programming, Biostatistics, Epidemiology and Medical Writing leadership identifying technology needs and opportunities, training needs, documentation and qualification verification and the most efficient practices for utilizing these new technologies within study development and execution. The Principal Programmer – Data Science Systems will also be responsible for developing, maintaining, managing and updating department Standard Operating Procedures (SOPs) and other materials for the implementation and utilization of emerging technologies within the department for Regulatory filing deliverables.
He or she may also be responsible for supporting the Biostatistics and Statistical Programming groups during the development of a Clinical Study Report or analysis. Their primary objective will be to implement emerging technologies within the development of a study and develop code, tools and application that will support the analysis. He/she must possess extensive experience and proven industry skills in the use of technologies such as R Studio / Python / C++ / C# / Java / AI / Machine Learning and other innovative software and technology. Limited experience with SAS is also required and knowledge of CDISC data standards, the reporting of clinical data and electronic submission of data to Regulatory authorities is expected / preferred. Clear understanding of validation methodologies and implementation strategies is also required.
• Identify opportunities for the implementation of emerging technologies in the day to day operations of the QS organization.
• Develop, maintain, implement, and manage applications developed utilizing this technology within the QS organization.
• Coordinate project direction by internal and external collaborators in the development, validation, qualification and deployment of new tools and technologies within the QS organization.
• Manage the life cycles of the new technologies including the software’/application versioning, training, user documentation etc.
• Develop and implement Standard Operating Procedures required for using this new technology in production development of Regulatory deliverables.
• Review clarify and process change requests for the applications.
• Serve as the primary liaison representing QS with Alexion IT in the development, validation and deployment of tools utilizing emerging technologies for GxP deliverables.
• Represent QS Statistical Programming in cross-functional /organizational development initiatives utilizing emerging technologies.
• Represent Alexion at relevant industry standardization congresses and working groups (e.g. PHUSE) identifying, documenting and presenting Pharma trends in the area of emerging technologies for QS.
• Serve as a subject matter expert on emerging technologies during regulatory audits as required
• Provide training as required for all DOQS and Contract staff for applications and tools developed with emerging technologies.
• Develop, maintain, implement, and manage department analysis architectures and applications utilized in the analysis of clinical study data.
• Collaborate closely with Biostatistics, Epidemiology, Medical Writing, Clinical Data Management, IT and Transformation to address cross functional needs where emerging technology may provide innovative solutions.
• Manages all aspects of the applications and tools developed with emerging technology including licenses, applications, processes, services, performance, networking, and users. Proactively monitor the applications to ensure ongoing availability and performance metrics are met
• Manage and administer user access and security for emerging technology as required.
• Recommends development of or adoption/incorporation of new methodologies and standards for supporting information management.
• Researches and evaluates alternative solutions and recommends the most efficient and cost-effective solution.
• Serve as a backup Administrator of the Alexion Statistical Programming SAS analysis environment.
• Any other activities as required.
• 7+ years programming experience in the pharmaceutical / biotech or CRO Industry.
• Advanced industry experience and extensive working knowledge of emerging technologies such as R, Python, C++, C#, Java, AI and / or machine learning procedures.
• 2-5 years project management experience in the CRO or Pharmaceutical Industry.
• Experience with CDISC SDTM and ADaM models and clinical analysis reporting is preferred.
• Proven abilities to lead and manage cross-functional projects from concept to completion.
• Strong verbal and written communication skills with ability to clearly and effectively present information.
• An understanding of the roles and responsibilities of all related disciplines within the QS department, in particular Biostatistics, Clinical Data Management, Epidemiology and Medical Writing is preferred.
• Working experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs is preferred.
• Knowledge of clinical database design, specifically electronic data capture and management and the implementation of external data sources is preferred.
• Advanced experience with:
o Constructing technical programming specifications.
o Relational Databases.
o Good Clinical Practices.
o Good Programming Practices.
o 21CFR Part 11 Standards.
o Creating all files necessary to support an electronic submission in the eCTD format.
• BS/MS/MA in Statistics, Biostatistics, Computer Science, Data Science, Mathematics or related area