View all jobs

Clinical Statistical Programmer

Chicago, Illinois
Clinical Statistical Programmer
Chicago, IL (onsite from day 1)

Major Tasks of Position:
  • Understanding of clinical trial objectives, design, endpoints and procedures defined in Protocol and Statistical Analysis Plan (SAP).
  • Develop programs that convert raw SAS datasets into standard format and improve existing programs by creating standard programs and macros.
  • Collaborate with manager and other programmers through participation in formal and ad-hoc meetings.
  • Assist manager through contributions to continuous improvement by developing standard programs and macros that follow CDISC guidelines required for regulatory submissions.
  • Independently program CDSIC, ADaM datasets.
  • Create ADaM Specifications & datasets from SDTM datasets per CDISC analysis data model standards and SAP.
  • Provide validation support to create SDTM+, SDTM and/or ADaM datasets / TLFs & documentation as per the specifications within set timelines
  • Program data displays (tables, listings, graphs) for inclusion in documents including publications, statistical reports, clinical study reports, and other regulatory documents, as required.
  • Independently develop QC programs to validate peer programmers’ SDTM, ADaM datasets, statistical tables, listings, and graphs                                                                       
  • Requirements:
  • Demonstrate proficiency of programming skills. Must have exp of ONC and efficacy programming.
  • In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Strong Base SAS v9.2 or later; SAS-STAT, and SAS Macro experience.
  • Ability to work on multiple tasks and prioritize tasks.
  • Excellent analytical, problem-solving, organizational, time management, interpersonal and communication skills.
  • QC experience.

  • Bachelor’s degree in Computer Science, Statistics, mathematics, Engineering or related field with minimum 6 years of related experience. Preferrable degree with Statistics or mathematics courses
  • Required skills: Create ADAM datasets from SDTM datasets according to CDISC analysis data model standards; Independently write, test, run, document, maintain and QC SAS programs and macros to generate SAS datasets, spreadsheets, data listings, tables and graphical displays of clinical trials data;
  • Prior experience working with Data Management on edit checks etc is preferred
  • Good knowledge of statistical programming languages (including SAS)

Please send your resume to sudhanshu@reqroute.com
Companies across U.S. have engaged ReqRoute, Inc to deliver skilled, dedicated IT professionals. Recruiting is our passion and we support Fortune 1000 companies with their hiring needs. We always seek to deliver competitive and sought-after career opportunities to our potential consultants and employees. We invite you to review the position requirements and apply today if your skills match our needs.  
ReqRoute, Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. (www.reqroute.com)

Share This Job

Powered by