Principal Clinical Programmer - Remote

Overview

The Principal Clinical Programmer will be responsible for support of team data review, data reconciliation and edit checks, and programming submission ready SDTM deliverables. This position will report to a Director of Clinical Programming or higher and will interact regularly with internal and external biostatisticians, clinical data managers, and other team members. Demonstrated ability to prioritize work and to effectively communicate and collaborate with key stakeholders both within Biometrics and beyond (research, translational science, clinical science, clinical operations and regulatory) is a must.

In Short

• Working from specifications developed by Data Management, independently build and execute programs for internal data reviews, data reconciliation, and edit checks.
• Lead in the development and maintenance of clinical programming related standards and tools.
• Work with data management to review case report forms, database specifications and similar documents.
• Independently 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.
• Performs stakeholder management, negotiating timelines and scope of deliverables.
• Participate in standards governance and developing biometric department operational processes.
• Mentor Clinical Programming staff as needed.

Requirements

• 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.
• Minimum 6+ years of biotechnology or pharmaceutical experience, with (immuno-) oncology experience preferred.
• Advanced programming experience in SAS. Experience working with other languages (R) in validated environments is a plus.
• Solid, demonstrated experience with CDISC data standards (CDASH, SDTM).
• In-depth knowledge of data standards and 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.

Benefits

• Competitive market-based salary.
• Opportunity to participate in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.