Responsible for leading statistical programming activities for clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g., analysis datasets, tables,). As part of the Statistical Programming team, provide technical expertise to the development and programming standards and procedures. May be responsible for personnel management of assigned team members including work allocation, performance management, and training/mentorship.
Statistical Programming and Analysis
Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data.
Generate SDTM domains, ADaM datasets, and Define.xml files.
Perform quality control for statistical programs and other study documents (e.g. presentations and reports).
Document the quality control review process.
Review output across programs to ensure consistency.
Review, maintain, and approve study documents per standard procedures.
Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
Subject Matter Expertise and Mentorship
Provide technical oversight and leadership in the areas of analysis and reporting.
Participate in process improvement initiatives and the development and/or maintenance of departmental procedures and standards.
Act as a subject matter expert when supporting company analytical projects.
Oversee work allocation and support performance management of assigned team members·
Train/mentor team members on statistical programming procedures and guidelines.
Provide efficient and effective capacity management.