Ref #: 31740

Employment type: Permanent - Full-Time

Location: Europe

Posted: 01-Sep-2021


Title: Senior & Principal SAS/SDTM Programmers (Senior, Lead and Principal Levels) – Multiple Roles
Duration: Full Time Permanent Employment
Location: Multiple EU countries; UK, Ireland, Belgium, Netherlands, France & Germany, Hungary, Poland or South Africa.

• Providing expertise, delivery and oversight of technical clinical data management activities from study set-up, including data stream integrations, to submission-ready tabulation packages.
• Responsible for mapping, programming, and validation of standardized clinical trial data and submission-ready tabulation packages.
• Providing leadership for three high-complexity studies or at least five moderate complexity studies in parallel ensuring project timelines and quality targets are consistently achieved.

• Lead and manage the assigned programming team’s deliverables at the study and program level to ensure project objectives are met within budget, to agreed timelines and to the highest standard of quality.
• Serve in a client-facing capacity that demonstrates the ability to anticipate client needs and implement innovative solutions, as appropriate
• Adhere to programming specifications and study specific requirements, including completion and filing of required documentation.
• Plan, organize and prioritize workload to ensure effective time management and adherence to project specific timelines.
• Efficient use of SAS including SAS® LSAF, and adherence to SAS programming guidelines.
• Create complex programs (such as project or departmental macros) to a high standard of quality and accuracy.
• Validate complex programs (such as project or departmental macros) per departmental procedures.
• Set-up standard programming directories and start-up utilities.
• Trouble-shoot and resolve programming issues in a timely and efficient manner.
• Provide specifications for data models to be used for quality review and for final data model (SDTM or other); design mapping algorithms for non-standard conversions.
• Ensure development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-for purpose data models and transfer intervals
• Ensure quality review of datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc) and compliant for Database lock.
• Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements

Experience Requirements:
- At least 5 years (for Senior) & 7 years (for Principal) of relevant experience in pharmaceutical industry within clinical trials programming using SAS
- University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree
- Expert knowledge of SAS programming, Define.xml, SDTM aCRF, cSDRGs.
- Expert knowledge of data structures (e.g., CDISC SDTM), software development lifecycle and their implementation.
- Vendor management oversight experience including defining data transfer agreements would be highly beneficial