Job duties:

• Development of study outputs including SDTM/ADaM datasets, tables, listings, figures and QC of requested output.
• Participate in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses.
• Interact with internal departments of the sponsor – Biostatistics, Data Management, Regulatory Operations and Medical Writing.
• Collaborates with peers and statisticians to ensure the submission readiness of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
• Involvement with creation and maintaining programming specifications for SDTM, ADaM and integration of data in support of ISS/ISE.
• Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
• Perform additional statistical analyses including but not limited to: support responses to regulatory agencies; generate integrated summary of safety and efficacy; support publications and presentations; support planning and reporting of clinical trials via exploratory analyses of available data; replicate vendor and statistician analyses for QC.

Our expectations of you:

• 5 years or more in SAS programming for clinical trial data.
• Bachelor’s degree in Math, Stats, Computer Science, Pharmacy, Biology or related.
• Strong knowledge in CDISC standards (SDTM, ADaM).
• Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG.
• Knowledge of pharmaceutical clinical development – understanding of safety deliverables and efficacy analysis supporting regulatory submissions.
• Knowledge of base SAS, proc report, exposure to macros, current CDISC data structures, and standardization methodology; demonstrated ability to debug SAS programs.
• High degree of technical competence in SAS Macro programming, SAS SQL, XML, RTF, and PDF.
• Demonstrated teamwork, pride of ownership, accountability, problem-solving and innovative skills.