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

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.

Qualifications:

• 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

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