Clinical Data Programmer
HeartFlow - Redwood City, CA

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Job Responsibilities :
  • Processing of clinical data required for analysis of company clinical trials.
  • Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
  • Program SAS to integrate and reconcile data from external sources for past, current and future planned clinical trials.
  • Generate SAS code to help automate weekly reports created by the Clinical Research team.
  • Generate and quality-check summary tables, data listings and graphs for in-house analyses of study data for publications using SAS standard coding practices.
  • Create/acquire tools to improve programming efficiency or quality. Validate work of other programmer/analysts and statisticians.
  • Assist in the creation/review of data management plans, specifications for datasets and annotated eCRFs.
  • Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
  • Support data queries from other functional groups (Technology, Production, Regulatory, and Marketing).
  • Assist in the development of[AW1] , data-entry and data handling guidelines/SOPs, eCRFs and other study support documentation.

Skills Needed :
  • Familiarity with CDISC/ Study Data Tabulation Model (SDTM).
  • Excellent knowledge of SAS programming and associated features and their applications in medical device research and in particular, a clinical trial data setting.
  • Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.
  • Willingness to help out in other areas of clinical research, trial design and planning, trial management, data management, and report writing.
  • Track record of generating new ideas and solutions to data analysis.
  • Thorough understanding of relational database components and theory.
  • Excellent oral and written communication skills.
  • Familiarity with ICH/GCP and 21 CFR part 11.
  • Some travel required; will occasionally conduct site visits, attend investigator meetings or vendor visits/audits.

Educational Requirements & Work Experience:
  • A minimum of a Bachelor's degree in Computer Science, Mathematics, Statistics, pharmaceuticals Sciences, Life Sciences and related areas is required. Statistics degree and strong understanding preferred.
  • A minimum of 2 years hands on relevant career experience in the pharmaceutical, medical device or biotechnology industry.
  • SAS certification (v9.2 or later).