Various consulting and full-time job opportunities from three years SAS experience in clinical environment to Senior and Management levels. Statistician positions also offered.
 
Positions would require relocation in the San Francisco Bay Area. Relocation package may be offered.
 

 
DUTIES :
 
• Provide statistical programming expertise and hands on support to clinical projects across multiple therapeutics areas.
 
• Lead statistical programming activities for clinical studies and participate in clinical study team meetings.
 
• Provide strong technical programming support to Biometrics and Data management. Contribute to activities in statistical systems development, validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools.
 
• Contribute in development and implementation of programming standards and conventions.
 
• Verify data quality by providing ad-hoc analysis. Work closely with Biostatistics to create analysis files specifications and analysis outputs (TFL) following the instructions provided in Statistical Analysis Plan (SAP).
 

 
SKILLS :
 
• Responsible for processing of clinical data required for analysis of clinical trials for Phase 1-4.
 
• Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
 
• Generate and QC summary tables, data listings and graphs for in-house analyses of study data or publications using SAS standard coding practices.
 
• Create/acquire tools to improve programming efficiency or quality Validate work of other programmer/analysts at CRO or in-house.
 
• Create/review programming plan, specifications for datasets and TLFs.
 
• Familiar with CDISC conventions, i.e., SDTM and ADaM models and hands on experience implementing these models.
 
• Work with other functional groups to identify areas where statistical programming support can enhance efficiency and quality.
 
• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. Support data queries from other functional group (Data Management, Medical Writing, Clinical Development, Clinical Operations, Regulatory, and Marketing).
 
• Excellent knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment in particular clinical trial data setting.
 
• Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.
 
• Track record of generating new ideas and solutions to data analysis.
 
• Excellent oral and written communication skills.
 

 
EDUCATION :
 
• A minimum of a Bachelor’s degree in Computer Science, Mathematics, Statistics, pharmaceuticals Sciences, Life Sciences and related areas is required. A Masters or PhD is preferred.