About the Opportunity
We are currently partnered with a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. They serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
- Provide on-time delivery with high-quality service
- Independently develop and/or QC SDTM and ADaM programming specifications, following the CDISC standards, and other programming supporting documents
- Independently develop and/or validate SDTM, analysis datasets, tables, figures and listings
- Generate Define-XML package for FDA submission
- Lead a team to successful completion of a project within given timelines and budget
- Independently interact with Sponsors with regard to statistical programming issues
- Design and specify study data tabulation models and analysis data models for clinical trials or for the integration of clinical trial data from multiple trials (e.g. ISS and ISE datasets). These designs and specifications are completed in accordance with common industry standards and conventions, statistical requirements and specifications, and/or clinical trial sponsor’s requirements
- Develop, apply, and provide expertise in statistical and data management methods and techniques.
- Responsible for providing statistical and programming input into database design for assigned projects, and overseeing efforts in development, validation and testing of the study databases.
- Will create table, listing, and figure (TFL) shells and specifications, and generate/validate TLF outputs.
- Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program/projects.
- Performs and coordinates preparation, execution, reporting, and documentation of high quality statistical analysis according to SAP.
- Responsible to function as a technical and operational leader interfacing with clients and leading internal statistical and programming teams to achieve clinical development project/program objectives.
- Minimum of a Master’s degree within Computer Science, Statistics and other math related degrees