Manage the Clinical Programming personnel. Collaborate with data management and Biostatistics colleagues to meet clinical development team goals. Work in team setting with peers to provide programming tools for the Biostatistics Department in support of multiple drug development projects. Ensure that programming work is done in a consistent manner and validated according to department practices.
Part A: Duties and Responsibilities
Identify and manage programming resources and deadlines according to clinical development team needs in association with other managers in Biometrics. Recruit and train Clinical Programmers as appropriate.
Define the process for integration of activities (data transfer, programming standards, etc.) with development partners and CROs.
Train, coach and evaluate Clinical Programmers and supervise contract programmers. Support career development of Clinical Programmers.
Work to develop, implement, and maintain standard Clinical Programming Checks and other data integrity checks. Ensure that the necessary user support is provided.
Work with study teams to define and implement custom Clinical Programming Checks as needed.
Maintain and document the Data Repository.
Prepare data, documentation, and analysis programs for eCTD submissions.
Provide consulting and support for applications software. Help train others in the use of generalized applications software.
Oversee the design, development, and maintenance of integrated project safety databases.
Oversee the close-down and archival of project electronic information.
Seek continuous process improvement.
Develop, maintain and disseminate Theravance SDTM standards to SDTM vendors.
Oversee production of TFLs for DSURs and similar reports.
Review data transfer agreements and EDC system metadata. Part B: Additional Duties and Responsibilities (if applicable)
Expertise with SAS software, programming standards and accepted software development techniques.
Expertise in SDTM standards and mapping.
Knowledge and familiarity with data base theory, specifically relational database concepts and SQL.
Expertise in the UNIX or Windows programming environment.
Thorough understanding of the clinical trials design and reporting process and Regulatory reporting requirements.
Experience interacting with others for defining and implementing user defined reports.
Understanding of basic Statistics.
BS Degree in Statistics, Computer Science or equivalent. MS degree preferred.