Lead Data Standards, Clinical Reporting

Job Description

We are currently seeking a Lead Data Standards, Clinical Reporting to join our growing team. In this role you will act as a lead in data standards, supporting all CDISC activities for the clinical reporting production programming and verification for client regulatory submissions and publications. Critical client project activities are reporting database development (SDTM and ADaM), preparing standards for the client, creating define.xmls and review of Pinnacle 21, statistical and clinical reporting, verification and submissions support.

Specific responsibilities include:

  • Lead and support the generation of analysis datasets, statistical analysis, listings, figures, and tables
  • Perform SAS programming and analysis support of the generation of analysis datasets, statistical analysis, listings, figures, and tables
  • Develop SAS application code
  • Perform validation of SAS programs and deliverables
  • Assist in designing data presentations
  • Perform SDTM and ADaM mapping
  • Generate SDTM and ADaM deliverables
  • Interface with a cross-function of client and Navitas Data Sciences team members;
  • Serve as an expert in two or more areas that may include Project Management, SCE, SDTM, ADaM, define.xml, SAS programming, deliverables process, Tables, Graphics, PK/PD, Registries or other areas
  • Lead one project team at a client

Desirable Skills and Experience

  • 15+ years pharmaceutical or CRO industry experience in CDISC, clinical reporting, and statistical programming
  • Strong competence in SAS/Base, SAS/Macro, and SAS/STAT programming
  • Supervisory experience
  • Expert knowledge of CDISC, SDTM and ADaM
  • Expert knowledge of SAS-based statistical programming
  • Proficiency in SAS programming on multiple platforms and operating systems, e.g., Windows, UNIX, etc. is desirable
  • Proficiency in R Programming is desirable
  • Excellent interpersonal and communication skills
  • Motivation and skills for growth into project management is desirable
  • Background in statistics and statistical analysis

US - Remote

Bachelor’s Degree in Computer Science, Statistics or equivalent, Master’s degree preferred


Data Sciences

Full Time

15 Oct 2021