Key Accountabilities/Core Job 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.
- Keeps abreast of industry trend, best practices and improves statistical programming methodology.
- Prior macro development experience is a must.
- Ability to use professional concepts to achieve objectives in creative and effective ways.
- Experienced in managing multiple projects.
- Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM).
- Minimum 12 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.
Education Requirements (degree, certifications, etc.):
- MS or higher degree in Statistics, Math or Computer Science