Clinical SAS Programmer

South san francisco, CA

POSITION SUMMARY:

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • 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
  • Generates CDISC SDTM and ADaM files; 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, perform ad hoc analysis and generate outputs according to the requirements
  • 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
  • Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection

KNOWLEDGE AND SKILL REQUIREMENTS:

  • Minimum 8 years Pharmaceutical/Biotech programming experience
  • Degree in Statistics or other related discipline required
  • 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 required
  • 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 submission experience is highly desirable
  • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports

Experience

8 (Yrs)

Salary

$130,000 - $150,000 a Year

Skillset

Base SAS SAS/MACRO Data Management Data Validation Define.xml SDTM ADaM SAS/ODS NDA Submission Ad Hoc Analysis

Location

South san francisco, CA

Telecomute

No