On behalf of our client, a leading North American provider of Clinical Data Management company serving the Biotechnology, Pharmaceutical and Medical Devices industries, we are recruiting for a Statistical Programmer Analyst to join this highly respected and growing organization.

Responsibilities:

Prepare SDTM/ADaM specification documents
Review SDTM/ADaM specification documents and provides feedback to the Project Manager and appropriate project team members
Perform SDTM/ADaM validation checks via SAS programming
Review SDTM/ADaM validation issues and provide resolutions to issues
Review SDTM mapping of eCRF
Assist/Prepare SDTM/ADaM submission packages (reviewer’s guide, define.xml, etc.)
Program SDTM, ADaM, TLF and other statistical programming
Perform quality control self-checks to ensure that all output meets quality standards and project requirements
Assist in the review of project documentation (TLF shells, TLF outputs, etc.) to ensure output meets quality standards and project requirements
Update QC logs with proposed resolutions/actions to QC findings for TLFs
Develop specifications and programs for data transfers and assist in their review to ensure the datasets meet the specifications Perform high-level data-driven and content review of all statistical programming deliverables, identify and resolve issues
Act as project-specific manager of SDTM tasks ensuring all tasks and timelines are maintained
Provide updates to Project Manager on SDTM tasks
Provide project-specific SDTM expertise at Sponsor TCs and meetings

Required Skills/Experience

3-5+ years of experience with SAS in Pharmaceutical/Biotech Industry
Knowledge of CDISC including SDTM/ADaM standards
Experience writing SDTM/ADaM specifications
Ability to troubleshoot SDTM/ADaM data validation issues
Knowledge of clinical data management, including data validation techniques
Detail oriented, high level of accuracy
Effective interpersonal and collaborative skills
Ability to handle multiple projects and deadlines
Strong technical writing skills
Demonstrated project management skills

We thank all applicants for their interest and will contact all who are qualified to discuss further.