Clinical Data Management Programming Specialist

You will be joining an international and multi-cultural company that includes over 30 different nationalities with English as our working language. Our employees are our strongest asset. Our customers value our flexibility, responsiveness, and proactive approach.

By joining a group of 6 highly skilled Clinical Data Management Programmers, in the Clinical Data Management team of over 40 people, the successful candidate will strengthen the team in Raleigh, NC. This is a hybrid role requiring weekly office presence. 

Your role:

As a Clinical Data Management Programming Specialist, your primary objective is to oversee the development of all SAS, or alternative advanced Clinical Intelligence reporting tools, and establish the corresponding SDTM datasets. This involves crafting SAS programs essential for manual data cleaning, coding, and reconciliation processes. Additionally, effective communication with the study team members is imperative to address data reporting needs and troubleshoot any encountered issues efficiently.

Your responsibilities:

• Creation of SDTM deliverables (SDTMIG v3.3, v3.4 / SDTM v1.7, v2.0) – both as production (main) or QC (double) programmer
• SDTM specifications
• SDTM annotations
• SDTM datasets including trial design tables, external data reconciliation/integration, external dictionary codings integration
• Define.xml: Creation of relevant metadata and generation and review of submission-ready define.xml
• Csdrg: Being an author and/or substantial contributor (not reviewer) of the Study Data Reviewer’s Guide for clinical data (CSDRG)
• Pinnacle 21 Community: Running Pinnacle 21 Community Version, independently assessing results and addressing accordingly to ensure CDISC compliance
• SDTM unblinding
• SAS DVP programming/Edit checks
• Thorough understanding of clinical data structures that allows for critical review of specifications. Being able to design robust checks based on eCRF and DVP.
• SAE reconciliation
• SAS reports/listings

• Must be local to Raleigh, NC and comfortable with a hybrid work environment 
• University degree in data science, biology, or similar is preferred 
• Comfortable with clinical data structures
• Strong affinity with clinical data
• Proficiency in programming languages commonly used in clinical data management such as SAS and SQL
• Experience working with electronic data capture (EDC) systems
• Knowledge of CDISC standards and guidelines
• Ability to collaborate effectively with cross-functional teams
• Detail-oriented with strong analytical skills
• 5 years of experience with SDTM deliverables using SAS
• Strong affinity with proc SQL, sas macro
• Independent issue solving skills
• Ability to respect planning/timelines and proper communication to PM/Supervisor/Team
• Working knowledge of English