Summary

The Senior Clinical Programmer Contractor 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 Senior Manager 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.

The ideal candidate will come with years of solid industry experience working in a regulated global environment while also demonstrating know-how, flexibility and scientific curiosity useful for establishing internal infrastructure, developing analysis standards, and driving both formal and exploratory work.

Responsibilities

• Working from specifications developed by Data Management, with some support build and execute programs for internal data reviews, data reconciliation, and edit checks.
• Assist in developing/maintaining clinical programming related standards and tools.
• Work with data management to review case report forms, database specifications and similar documents.
• With some support, 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.
• With minimal supervision, performs stakeholder management, negotiating timelines and scope of deliverables.
• Participate in standards governance and developing 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.
• Minimum 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).
• Good 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.

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