The Senior Statistical Programmer is responsible for developing, validating, and executing SAS programs to analyze clinical trial data, ensuring full compliance with CDISC standards (SDTM/ADaM).

Key Responsibilities

• Lead the programming of complex CDISC-compliant datasets (SDTM and ADaM).
• Generate and validate Tables, Listings, and Figures (TLFs) for Clinical Study Reports.
• Perform independent double-programming to ensure 100% data accuracy and integrity.
• Develop and maintain company SAS macros to automate repetitive programming tasks.
• Prepare documentation for regulatory submissions, including Define.xml and Reviewer’s Guides.

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The Senior Clinical Data Manager oversees the end-to-end data management lifecycle, ensuring that clinical database systems are designed and maintained to produce high-quality, submission-ready data.

Key Responsibilities

• Design and validate Clinical Databases (EDC) and Case Report Forms (eCRFs).
• Develop Data Management Plans (DMP) and Edit Check Specifications.
• Manage data cleaning activities, including query generation, resolution, and medical coding.
• Collaborate with biostatisticians to ensure data structures meet analysis requirements.
• Lead database lock procedures and ensure all documentation meets GCP (Good Clinical Practice) standards.

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The Clinical Systems Developer builds specialized software tools and automation pipelines to improve the efficiency of clinical data processing and reporting.

Key Responsibilities

• Develop custom applications or web tools to streamline clinical data visualization and tracking.
• Integrate SAS with other clinical technologies (EDC, IVRS, etc.) via APIs or ETL processes.
• Maintain and optimize clinical data repositories and automated validation tools (e.g., Pinnacle 21 automation).
• Troubleshoot and resolve technical issues within the clinical programming environment.
• Collaborate with the IT and Clinical teams to implement innovative tech solutions for trial efficiency.

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