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Company Overview:
Cencora is a leading organization in the pharmaceutical/biotechnology industry, dedicated to advancing healthcare through cutting-edge research and development. With expertise spanning supply chain innovation, clinical trial support, and strategic consulting, we are committed to improving patient outcomes and are looking for a talented Senior Statistical Programmer to join our dynamic team.
Job Summary:
We are seeking a highly skilled Senior Statistical Programmer with extensive experience in CDISC-compliant statistical programming.
The Statistical Programmer will act as a subject matter expert (SME) in CDISC data standards and a project manager responsible for coordinating the preparation, execution, reporting and documentation of statistical programming activities internally and externally. This role requires deep expertise in CDISC-compliant programming, thorough understanding of regulatory submission requirements of data packages, and the ability to act as programming project lead across internal and external teams.
Key Responsibilities:
- Lead and contribute to the development, review, and documentation of CDISC-compliant dataset specifications and data sets, with primary focus on SDTM and ADaM; serve as an SME for CDISC standards governance.
- Perform quality control (QC) of CDISC dataset specifications, derived datasets, and standard or custom tables, figures, and listings (TFLs) to ensure quality and compliance with CDISC standards and regulatory guidelines.
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