Biostatistical Programming Manager
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Job Summary
Working remotely in a full-time capacity, the Biostatistical Programming Manager will oversee the product programming function, collaborate with multidisciplinary teams, and ensure the timely development of statistical datasets and analysis outputs in support of biosimilar products.
Key responsibilities
- Represent the product programming function in project team meetings and collaborate with statisticians and CROs
- Coordinate the development of dataset specifications and oversee the implementation of TLGs according to statistical analysis plans
- Lead and manage programming activities, ensuring compliance with standards and addressing resource and quality issues proactively
Required qualifications
- BA/BSc or higher degree in quantitative or scientific subjects
- At least 8 years of relevant statistical programming experience in a clinical development environment
- Advanced SAS programming skills, including BASE, STAT, Macro, and Graph
- Working knowledge of CDISC SDTM, ADaM, and Define-XML standards
- Ability to lead and manage programming teams effectively
Complete Job Description
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