Sr. Statistical Programmer Analyst

Location: San Francisco, CA

Responsibilities:

  • Provide statistical programming expertise and hands on support to clinical projects across multiple therapeutics areas
  • 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
  • Perform vendor qualifications in regards to statistical programming function and oversees and validate vendor’s programming activities such as CDISC implementation, analysis files specifications and analysis and programming conventions
  • Work closely with the company’s Data management to assure data quality by providing ad-hoc analysis
  • Work closely with the company’s Biostatistics to create analysis files specifications and analysis outputs (TFL) following the instructions provided in Statistical Analysis Plan (SAP)
  • Proactively applies professional concepts to contribute to development of the company’s concepts and principles and to achieve objectives in creative and effective way
  • Provides guidance on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables
  • Exercises independent judgment in developing methods and procedures on new assignments
  • 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 modelsl and hands on experience implementing these models
  • Provide guidelines, review and QC CRO deliverables to ensure the quality of deliverables
  • 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 (Medical Writing, Clinical Development, Clinical Operations, Regulatory, Marketing)

Qualifications/Skills

Minimum of a Bachelor’s degree in Computer Science, Mathematics, Statistics and related areas in required

  • Masters or PhD is preferred
  • Equivalent experience may be acceptable
  • A minimum of 8 years hands on relevant career 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 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 application development skills
  • Thorough understanding of relational database components and theory
  • Excellent oral and written communication skills