Senior Clinical Programmer – Contractor

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the review of team data, data reconciliation, and edit checks, as well as in the preparation of submission-ready SDTM deliverables.

• Develop and implement programs for internal data evaluations, data reconciliation, and edit checks.

• Contribute to the establishment and maintenance of clinical programming-related standards and tools.

• Collaborate with data management to assess case report forms, database specifications, and related documents.

• Create data transfer specifications and oversee the transfer of external data.

• Program SDTM datasets and generate associated CDISC deliverables such as aCRF, define.xml, reviewer’s guide, etc.

• Manage stakeholder relationships by negotiating timelines and the scope of deliverables.

• Engage in standards governance and contribute to the development of operational processes within the biometric department.

⛳️ Requirements

• A Bachelor’s or Master’s degree in a data science discipline, such as statistics, mathematics, epidemiology, computer science, bioinformatics, or a related field with equivalent experience.

• At least 4+ years of experience in biotechnology or pharmaceuticals, with a preference for experience in (immuno-) oncology.

• Proficient programming skills in SAS.

• Familiarity with additional programming languages (e.g., Unix scripts, AI tools, R functions/packages, etc.).

• Strong understanding of CDISC data standards (CDASH, SDTM).

• Solid knowledge of data standards and proven experience in managing non-CRF data, including the ability to work with various data types, such as biomarker, PK/PD, pharmacovigilance, etc.

• Proven capability to quickly adapt to evolving project and strategic needs.

• Maintains a fit-for-purpose approach to both daily tasks and long-term objectives.

🏝️ Benefits

• Options for remote work.