Manager/Senior Manager Statistical Programmer

Responsibilities:

• Independently develop, validate, document and troubleshoot SAS programs for the preparation of internal reports, regulatory submissions, and ad hoc analyses. - Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance. - Create, validate, update, and document SAS programs to generate analysis datasets, data listings, tables, and graphs of high quality in a timely manner. - Support preparation of data packages, eCTD deliverables, and responses to regulatory agencies. - Collaborate with cross-functional departments and provide programming support as needed. Generate adhoc analysis as requested by cross-functional departments. - Contribute to the preparation of presentations for internal project teams, leadership team, and external audience. - Develop data edit checks to identify potential data issues and work with clinical data manager to issue queries. - Reviews and provides feedback on CRF designs, CRF annotations, SDTM/ADaM Specifications and SAPs. - Develop software tools, SAS macros and utilities to automate programming activities and improve programming efficiency and quality. - Provides guidance/oversight of statistical programming work being conducted by vendors, and contractors. - Oncology experience is preferred. Who You Are:

• Education: B.Sc. / M.Sc. in Statistics, Mathematics, Computer Science, Engineering or a related field. M.S. preferred. - 6 plus years of experience with SAS in pharmaceutical, biotechnology industry or CRO is required. - Strong expertise in CDISC including SDTM, ADaM, and Define.xml. - Experience in regulatory submissions (e.g., sNDA, NDA, IB and DSUR). - Excellent programming knowledge of SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH and SAS/Macro language