Overview
On Site
Full Time
Skills
Database Design
Scratch
Business Analytics
Business Analysis
Statistics
Computer Science
Public Health
Pharmaceutical Industry
SDTM
Digital Asset Management
CDISC
SAS/BASE
Writing
SAS
Specification Gathering
Clinical Trials
Clinical Research
Good Clinical Practice
Google Cloud Platform
Google Cloud
XML
Presentations
Job Details
Responsibilities:
- Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users.
- Use your expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design.
- Use study protocol, CRF, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implementation guides to independently author SDTM specifications from scratch; use Pinnacle 21 to run data conformance and create define.xml for SDTM and ADaM submissions.
- ct as the CDISC subject matter expert.
- Convert designs and specifications into computer code and analyze code to find causes of errors and revise programs.
- BA/BS in computer science, statistics, computer science, or public health with at least 5 years performing statistical programming in the SAS language within the CRO/Pharmaceutical industry.
- Extensive experience and understanding in SDTM model including transforming raw data files while adhering to CDISC standards from end to end (raw data to eSub); advanced understanding of SDTM model and experience with ; both specification, programming, and conformance of SDTM CDISC; strong CDISC skills with an emphasis on SDTM End to End submissions experience.
- DaM model and experience with both specification, programming, and conformance of ADaM CDISC is a plus.
- SAS/Base knowledge with an emphasis on data step programming; competency modifying pre-existing SAS code, as well as writing SAS code from specs.
- Clinical trials including knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (Google Cloud Platform) and International Conference on Harmonization (ICH) guidelines.
- Data/submission conformance tools (such as P21), creation of define.xml, SDSP, and study data reviewer's guides.
- Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and companies.
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