IQVIA

Senior Clinical Programmer, SDTM

IQVIA

full-time

Posted on:

Location Type: Office

Location: Frankfurt • Germany

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

Tech Stack

PythonSQL

About the role

  • Review and provide input into all trial set-up documentation
  • Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable
  • Creation of Data Review Model (DRM) based on current Client standards and SDTM datasets based on current SDTM standards
  • Creation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ)
  • Perform unblinding, data-cut activities for planned reporting milestones and database locks
  • Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as needed
  • Support the development of standards and drive implementation within the organization.

Requirements

  • Minimum 6+ years of relevant experience in SDTM Clinical Programming
  • Advanced knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R)
  • Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging
  • Advanced knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM
  • Demonstrated understanding of current industry standards for submission of clinical trial data
  • Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects
  • Ability to communicate with cross-functional teams and business partners and gather feedback for study specifications and/or data issues.
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SDTM Clinical ProgrammingSASSQLPythonRdata manipulationdata reportingDefine.xmlCDASHmetadata
Soft Skills
organizational skillsleadership skillscommunication skillscross-functional collaborationfeedback gathering