This position is responsible for overseeing and leading in the specification, production and QC of non-statistical clinical reports. This position oversees staff and works actively with key stakeholders, including Data Management and GPS, to understand requirements for non-statistical clinical reporting and implement these reports with high quality and on time. This position is responsible for taking a lead role in SAS programming support of centralized specification, production and QC of SDTM datasets for use by Statistical Programming and others, and in preparation for submission to regulatory agencies. This position serves as a highly skilled advisor to ensure high quality and proper conduct in support of above responsibilities.
* Oversees and leads in specification, programming, and QC of SAS programs in support of non-statistical reporting business needs, specifically for DM but also other Vertex departments such as Global Patient Safety
* Oversees and leads in specification, programming, and QC of SAS programs in support of CDISC SDTM dataset delivery to Statistical Programmers or regulatory agencies
* Engages appropriate stakeholders in communication to analyze user requirements, systems problems, and enhancements to current system’s capabilities
* Oversees team of programmers to implement non-statistical reports to support user needs related to raw clinical trials data , typically in SAS
* Leads in vendor relationships, timelines, and technical functions related to specification, programming, and QC of non-statistical clinical reports and SDTM datasets
* Leads activities across project boundaries when appropriate and integrates activities with those of other groups and departments as needed
* Analyzes and communicates assessment of resources and utilization of resources to support business needs
* May supervise staff engaged in these activities
* Performs other duties as assigned
* Master’s degree and 8+ years of statistical programming experience, or
* Bachelor’s degree and 10+ years of statistical programming experience
* Possesses expert knowledge in SAS programming and can mentor, train, develop clinical programmers in using SAS to perform complex data handling and non-statistical clinical data reporting
* Possesses hands-on knowledge of clinical trials lifecycle from data collection through production of statistical reports
* Expert in hands-on knowledge of DM clinical reporting needs
* Expert in hands-on knowledge of the CDISC SDTM model
* Possesses knowledge of regulatory requirements for clinical trials data handling and reporting
* Exhibits proficiency in tasks and skills including teamwork, planning, organization, delegation, coordination, and oversight of vendors
* Demonstrates a record of operational and ethical standards, and team improvement
* Exhibits strong communication skills with ability to impact and influence the decisions of a team
* Demonstrates innovation and creativity in aligning technology with and driving business objectives
* Strong communicator and able to present ideas, engage in dialogue with persons in a variety of other functions, especially Statistical Programmers, Biostatisticians, Data Management, and other departments engaged in providing data for SDTM packages or using non-statistical clinical reports
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.