FierceBiotech and FiercePharma Jobs
sr CDISC Analyst - TAKE Solutions Inc
Sep 24
Location: Princeton, NJCategories: All Categories
Website: http://www.takesolutions.com
Position Description
Senior CDISC Analyst
The successful candidate will have extensive knowledge and experience with clinical data specifically around CDISC SDTM standards.
Overview:
The appropriate Individuals will provide primary support study standardization to the CDISC SDTM by creating the SDTM design specifications, including the Annotated CRF and the specification documents. You will oversee execution of the specification by the SDTM standardization specialists, as well as manage the SDTM design specification life-cycle. You will work closely with the SDTM project managers, as the primary interface with clients during the standardization projects.
Qualifications:
•A Bachelors degree in the medical/technical field or relevant work experience
•4-6 years of experience working in pharmaceutical or CRO, specifically in Clinical Data Management or Biostatistics
•Impeccable verbal and written communication skills
•Ability to adapt to a constantly progressing industry
Technical qualifications:
•A minimum of 2 years experience in CDISC conversion
•Strong technical knowledge of CDISC SDTM model
•Clinical Data Management experience
•Extensive Microsoft Office experience
Key Responsibilities:
•Oversee the CDISC SDTM Standardization/Analysis process
•Perform as a team leader for the CDISC team including planning and executing meetings
•Mentor and guide the junior analysts
•Development of CDISC SDTM mapping specifications
•Creation of data definition files and Case Report Forms annotated to CDISC SDTM
•Communicate with clients on all project related issues or queries
•Ability to work on multiple projects simultaneously and meet last minute and scheduled deadlines
•Develop and manage SOPS and guidelines
•Update weekly, monthly and quarterly pipeline reports
