Job Details

Loc: San Francisco,

• CA Dur: 3 M+Description:RESPONSIBILITIES Provide statistical programming expertise and hands on support to clinical projects across multiple therapeutics areas. Provide strong technical programming support to Biometrics following the GCP, SOPs and good programming practices.
• Work closely with Biostatistics to create analysis files specifications and analysis outputs (TFL) following the instructions provided in Statistical Analysis Plan (SAP). 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.
• 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.
• Familiar with submission requirements of regulatory agencies. Work closely with Data Management to assure data quality.
• Support data queries from other functional group (Medical Writing, Clinical Development, Clinical Operations, Regulatory,
• Marketing). Perform other programming tasks as needed. QUALIFICATIONS Minimum of a Bachelor\'s degree in Computer Science, Mathematics, Statistics, and related areas is required.
• Minimum 8 years hands on relevant experience in the pharmaceutical or biotechnology industry.
• 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.
• Thorough understanding of relational database components and theory. Excellent oral and written communication skills.