Senior Clinical Programmer Contractor

Responsibilities

• Working from specifications developed by Data Management, with some support, build and execute programs for internal data reviews, data reconciliation, and edit checks.
• Aid in developing/maintaining clinical programming related standards and tools.
• Collaborate with data management to review case report forms, database specifications, and similar documents.
• Develop data transfer specifications and manage the transfer of external data.
• Program SDTM datasets and produce related CDISC deliverables such as aCRF, define.xml, reviewer’s guide, etc.
• Perform stakeholder management, negotiating timelines and scope of deliverables with minimal supervision.
• Engage in standards governance and develop biometric department operational processes.

Qualifications

• Bachelor’s or Master’s degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience.
• 4+ years of biotechnology or pharmaceutical experience, with (immuno-) oncology experience preferred.
• Good programming experience in SAS.
• Experience with other software languages (e.g., Unix scripts, AI tools, R functions/packages, etc.).
• Good knowledge of CDISC data standards (CDASH, SDTM).
• Demonstrated experience in the handling of non-CRF data including proven ability to work with diverse data types, such as biomarker, PK/PD, pharmacovigilance, etc.
• Demonstrated ability to rapidly adapt to changing project and strategic requirements.
• Takes a fit-for-purpose mindset to daily work as well as long-term vision.