The Clinical Programming Manager provides management oversight of personnel and project level activities within the SAS Programming department. This role works cooperatively with SAS programmers, specifically with other groups (DM managers, SDTM Programming group, JReview, Statistical/Biostatistician managers) to establish standardized and consistent operating procedures and to maximize the efficiency of the SAS Programming group. The Manager interacts with clients as needed for project and/or relationship management and helps the manager to prioritize activities across SAS Programming projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals which promotes teamwork and quickly restores department effectiveness. This role is responsible for staff development to facilitate succession planning and maintaining a programming staff with diverse skills, abilities, and competencies meeting the business needs of SAS Programming. This position requires the Manager to be with Hands on experience to support programming activities within the SAS programming group.
• Ensures that the SAS Programming department meets established timelines, provides high quality deliverables, complies with project requirements, and conducts projects within budget.
• Develop dashboard, standard tools and tracker using Data Visualization Tools such as Tableau, SAS Viya, JReview etc.
• Work on individual compound(s) or project(s) to develop Standard Programs and Macros.
• Identify opportunities for increased efficiency and consistency within Clinical Programming, JReview, SDTM and Dashboarding.
• Support Global Projects which involves collaboration with other cross functions.
• Assigns programmers to projects in a manner which keeps programmers at their utilization goal, and which matches programmers to projects appropriate to their skills, training, and experience, while also providing opportunities to work with varied projects, and teams.
• Keep in touch with standards CDISC, FDA, PMDA, EMA requirements and guide the group accordingly.
• Support submission related work and agency questions.
• Ensure all programming activities and processes performed are conducted according to standard operating procedures and good programming practices.
• Provide patient profiles, data reconciliation reports and ad-hoc reports for data review to support the clinical teams.
• Assist in preparing datasets for statistical analysis and regulatory submissions.
• Participate in review process of study documents such as the annotated CRFs/eCRFs, edit check specification.
• Program data edit checks, as necessary, to facilitate Data Management's data cleaning activities.
• Design and develop SAS macros, applications, and other utilities to expedite SAS programming activities and usage by the Oncology Data Management and other areas of Clinical for data review.
• Develop and maintain the programs including, testing, and organizing the SAS datasets, SAS programs, and related documentation.
• Candidate should have BS/MS in related field
• Minimum of 7 years of SAS programming experience and 2 years of Managing SAS group experience.
• Minimum of 3 years experience with JReview, RShiny or similar and experience in data visualization platforms preferred.
• Good understanding of standards specific to clinical trials such as CDISC, SDTM, MedDRA, WHODRUG.
• Knowledge of the EDC system, InForm, and underlying data structure is a plus.
• Knowledge of data management process, good understanding of data cleaning process