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Executive Order 11246, Section 503 & VEVRAA EOE, including disability/vets
FDA STAT GCP Consultant
(Jobs in Deerfield, IL)
 
Requirement id 88275
Job title Consultant
Job location in Deerfield, IL
Skills required Word And Excel, FDA, STAT, GCP
Open Date 06-Feb-2019
Close Date
Job type Contract
Duration 11 Months
Compensation DOE
Status requirement not found
Job interview type Face to Face interview
Apply
   Email Recruiter: coolsoft
Job Description Consultant: Word And Excel, FDA, STAT, GCP

Candidate must be your W2 Employee.

We should submitt only GC, GC EAD, L2 EAD, H4 EAD and Citizen.

Job Description :

Essential Duties and Responsibilities.

* 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.

* Prepare documentation on all production programming and validation activities; utilize best industry business practices and data standards for clinical data submissions to the FDA and other global regulatory agencies.

* Assist manager through contributions to continuous improvement by developing standard programs and macros that follow CDISC guidelines required for regulatory submissions.

* Independently program CDSIC SDTM, ADaM datasets.

* Map raw data to SDTM (Study data table model) in compliance with CDISC data model standards and create specifications for programming.

* Create ADaM Specifications & datasets from SDTM datasets per CDISC analysis data model standards and SAP.

* 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



Qualifications.

* Demonstrate proficiency of programming skills.

* 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.



Education and/or Experience.

* Bachelors degree in Computer Science, Statistics, Engineering or related field plus 5 years of related experience.

* Required skills: create SDTM datasets from raw data according to CDISC standards (5 yrs); Create ADAM datasets from SDTM datasets according to CDISC analysis data model standards (3 yrs); 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 (3 yrs);

* Prior experience working with Data Management on edit checks etc is preferred
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 88275 while calling.
 
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(Consultant: Word And Excel, FDA, STAT, GCP in Deerfield, IL)
     
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