Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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.
Act as the CDISC subject matter expert.
Convert designs and specifications into computer code and analyze code to find causes of errors and revise programs.
Requirements:
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.
ADaM 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 (GCP) 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.