- Lead on clinical studies and manage/provide training to lower level personnel when needed.
- 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.
- Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
- Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
- Ability to use professional concepts to achieve objectives in innovative and efficient ways.
- FDA submission experience is a must.
- Experienced in managing programming staff.
- Solid knowledge of CDISC standard (SDTM & ADaM).
- Minimum 5 years Pharmaceutical/Biotech programming experience
- NDA submission experience is a plus.
- Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
Education Requirements (degree, certifications, etc.): Include must have and preferred
- BS/MS in Statistics, Math or Scientific Discipline.