Function as a lead for statistical programming process improvement, CDISC SDTM/ADaM data standardization. Enforce the appropriate standards in the department and provide training. Responsible for planning and tracking the statistical programming activities such as designing, developing, validating, updating, and documenting SAS programs to generate analysis datasets, data listings, summary tables, and statistical graphs supporting safety and efficacy analyses.
- 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.
- Other duties as assigned.
- 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.
- 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).
- Solid knowledge of other software such as SpotFire, R Shiny etc. is a plus.
- BS/MS in Statistics, Math or Scientific Discipline.
Job Location: Cambridge, MA
Equal Opportunity Employer
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