Sr Statistical Programmer

 

key responsibilities:

• Lead on clinical studies and integrated analyses and provide guidance and training to other lower-level personnel.
• Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration.
• Contribute and implement to statistical analysis plans; provide additional expertise in the analysis of clinical trial when it relates to protocol development, case report form design and data collection.
• Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
• Work closely with Biostatistics to create analysis specifications following the instructions provided in Statistical Analysis Plan (SAP).
• Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's Guide for Electronic Submission.
• Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
• Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
• Help identify issues and initiates resolution of the problems.
• Act as a liaison between statistical programming, subcommittees and project teams as needed.
• May serve as external spokesperson for the organization.
• Create/acquire tools to improve programming efficiency or quality control.
• Stay current with industry trend, best practices and improves statistical programming methodology.
• Performs other duties as assigned.

 

Professional experience/qualifications:

• Minimum 5 years Pharmaceutical/Biotech programming experience including macro/tools development experience.
• FDA submission experience is highly desirable.
• Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• Ability to use professional concepts to achieve objectives in creative and effective ways.
• Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM).
• Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.
• BS/MS in Statistics, Math or Scientific Discipline