Principal Statistical programmer

Principal Statistical Programmer Responsibilities

• Project lead level activities.
• 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 usage for electronic submission from data received in non-standard form from various sources.
• Performs data analysis, statistical analysis, generates 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 teams, perform ad hoc analysis and generate outputs according to the requirements.
• Implements and contributes to statistical analysis plans; provides expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
• Recognizes inconsistencies and initiates resolution of data problems.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
• Acts independently to determine methods and procedures on new assignments.
• May provide guidance to other lower level personnel.
• Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP).
• Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
• 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.

• Minimum 8 years Pharmaceutical/Biotech programming experience.
• NDA submission experience and knowledge required.
• Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• BS/MS in Statistics, Math or Scientific Discipline.

Work Location:

Onsite in San Francisco Bay Area, CA