Description
As the Manager of Statistical Programming at this well-known company in the San Francisco Bay Area, applicants should be prepared to manage and coordinate the Statistical Programming staff to ensure efficient use of the resource and work flow. As well as design, develop, evaluate and modify computer programs to analyze and evaluate clinical data. Furthermore, they will generate study specific and ad-hoc clinical data listings, summary tables and figures.Core Job Responsibilities:
- Manage and provide guidance to lower level personnel.
- Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
- Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
- Performs 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.
- Review Data Management Plan, Data validation plan and edit check specifications
- Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
- Acts as a liaison between statistical programming, subcommittees and project teams as needed.
- Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
- May serve as external spokesperson for the organization.
- Generate and QC summary tables, data listings and figures for in-house analyses of study data or publications using SAS standard coding practices.
- Validate work of other programmer/analysts at CRO or in-house
- Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP)
- Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
Qualifications:
- M.S. in Statistics preferred
- Ability to use professional concepts to achieve objectives in creative and effective ways
- Experience in the analysis of complex Oncology clinical trial data.
- Solid knowledge of CDISC standard (SDTM & ADaM).
- Minimum 9 years Pharmaceutical/Biotech programming experience with management skill and experience.
- FDA submission experience is a plus