TITLE: Clinical Data Programmer
TYPE: W2 Contract
DURATION: 12+ Months
W2 CONTRACT, PLEASE NO CORP TO CORP
Primary Objective
A small pharma is seeking a clinical programmer who will assist the department head in programming data review listings and reports for assigned studies and provide other clinical programming support as needed. This role must effectively interface with Data Management and other cross functional areas involved in clinical data review.
RESPONSIBILITIES
- Programs SAS Non-System Edit Checks, Protocol Deviations and SAS Data Listings
- Ability to independently develop innovative and complex SAS programs to support activities including, but not limited to, data review and reporting
- Supports the maintenance of the Non-System Edit Check Global Library to ensure consistency across programs and studies and concordance with the EDC Global Library
- Create SAS program Specifications for Non-System Edit Checks based on CRF and non-CRF data.
- Responsible for participating in the development and review of data transfer specifications, processing of clinical data downloads and data transfers to/from service providers
- Create Clinical Data Review Tools [i.e., Data Listing Reports (DLRs); External Data Reconciliation Listings, Medical Safety Listings for reconciliation, etc.] for all studies based on study specific specs and requirements.
QUALIFICATIONS
- Minimum of BS/BA degree in related field
- 3-7 years of SAS programming experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of a portion of the years of experience
- Is fully conversant of SAS programming and best Clinical Data Management (DM) practices
- Knowledge of and experience with clinical databases, electronic data capture systems, quality control processes and auditing procedures
- Familiarity with Medidata Rave custom reports and BOXI reports desirable
- Strong critical thinking skills
- Familiarity with GCP, ICH and FDA requirements as they apply to clinical data
- Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
- Regular interaction with Data Management, Clinical Trial Management, and Medical Management groups
- Excellent written and oral communication skills
- Knowledge of industry standards (CDISC, SDTM, CDASH)
If you are interested in this Clinical Data Programmer opportunity, please do not hesitate to apply!!!
