Senior Statistical Programmer (FTE)
South San Francisco, CA
Phone, Email, Postal Address:
# of Openings: 1
How to Apply:
Apply through the Rigel Pharmaceuticals website www.rigel.com
The Senior Statistical Programmer is responsible for developing, evaluating, and modifying computer programs to analyze and evaluate clinical data. This role assists with maintaining the workflow for generating study specific and ad-hoc clinical data listings, summary tables and figures.
- – Acts as a liaison between statistical programming, data management, clinical operation, subcommittees and project teams as needed.
- – Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
- – Acts independently to determine methods and procedures on new assignments.
- – Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
- – Creates the specifications and programs for CDISC i.e. SDTM and ADaM datasets, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
- – Generates safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- – Reviews Data Management Plan, Data validation plan and edit check specifications.
- – Interacts with Statisticians and other clinical team members, performs ad hoc analysis and generates outputs according to the requirements.
- – Implements and contributes to statistical analysis plans; provides additional expertise in the analyses of clinical trials as it relates to protocol development, case report form design and data collection.
- – Recognizes inconsistencies and initiates resolution of data problems
- – Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
- – Develops SAS coding and table templates for preparing, processing and analyzing clinical data.
- – Suggests tools to improve programming efficiency or quality.
- – Establishes monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
Skills / Education Requirements:
- – BS/MS in Statistics or other related discipline.
- – 8+ years of Pharmaceutical/Biotech programming experience.
- – Solid knowledge of SAS Programming language required.
- – Strong SAS programming and management background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
- – Experience in the analysis of complex clinical trial data.
- – Ability to use professional concepts to achieve objectives in creative and effective ways.
- – Experience working with NDA submissions is highly desirable.
- – Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
Date Posted: 04-13-2020