Senior Clinical Programmer – SDTM

📋 Description

• Review and contribute feedback on all trial set-up documentation.

• Convert protocol and any relevant de-risking into the development and upkeep of comprehensive technical specifications, including mapping documentation, aCRF, and data transfer agreements as necessary.

• Develop a Data Review Model (DRM) in accordance with current Client standards and SDTM datasets based on prevailing SDTM benchmarks.

• Generate back-end edit checks, listings, and visualizations to facilitate risk-based central monitoring, such as Quality Tolerance Limits (QTLs) and Critical to Quality (CtQ), along with ongoing clinical and safety data assessment.

• Conduct quality control on all clinical programming outputs.

• Execute unblinding and data-cut tasks for scheduled reporting milestones and database closures.

• Create and validate electronic submission packages that meet the submission criteria set by FDA, EMEA, and other regulatory bodies as required.

• Assist in the development of standards and promote their integration within the organization.

⛳️ Requirements

• At least 4+ years of pertinent experience in SDTM Clinical Programming.

• Solid understanding of data structures and relevant programming languages for data manipulation and reporting, including SAS, SQL, Python, R, etc.

• In-depth knowledge of complex finding data types, such as biomarkers, and digital data sources including ECG and imaging.

• Advanced familiarity with SDTM, including Define.xml, CDASH, and metadata, along with experience in transforming vendor data into SDTM; knowledge of ADaM is a plus.

• Proven understanding of current industry standards for the submission of clinical trial data.

• Strong organizational and leadership capabilities to manage multiple competing priorities across various projects.

• Effective communication skills for collaboration with cross-functional teams and business partners, along with the ability to gather feedback on study specifications and data-related issues.

🏝️ Benefits

• Health insurance

• Professional development opportunities