Senior Manager, Statistical Programming - Oncology Early Development
$124,500–$236,500 year
HybridNorth Chicago, Illinois, United States
Job Summary
Lead statistical programming oversight for Oncology Early Development clinical projects conducted by CROs, ensuring data integrity and high-quality analysis from first-in-human trials through clinical proof of concept. Manage a team of statistical programmers, handle resource planning, and validate analysis datasets and TLFs delivered by CROs while supporting in-house studies. Develop and oversee SAS programs for ADaM datasets, tables, listings, and figures following CDISC standards, and create documentation for regulatory filings including reviewer guides and data definition documents. Lead the development of standard SAS macros and standard operating procedures, while mentoring staff and participating in recruitment. Requires an MS in Statistics or Computer Science with 9+ years of experience, minimum 2 years leading a team, and in-depth knowledge of SAS, CDISC, and the drug development process.
Required Qualifications
- MS in Statistics, Computer Science or a related field with 9+ years of relevant experience
- BS in Statistics, Computer Science or a related field with 11+ years of relevant experience
- Minimum of 2 years experience leading a team of statistical programmers
- In-depth understanding of SAS programming concepts and techniques related to drug development
- In-depth understanding of CDISC Standards
- In-depth understanding of the drug development process, including experience with regulatory filings
- Ability to communicate clearly both oral and written
- Ability to effectively represent the Statistical Programming Organization in cross functional teams
- Ability to accurately estimate effort required for project related programming activities
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