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EI
Hybrid Senior Manager, Statistical Programming
Posted last month
About the role
- Senior Manager overseeing statistical programming activities for clinical studies in a biotech setting. Managing timelines and ensuring programming quality and compliance with regulatory standards.
Responsibilities
- Lead and oversee statistical programming deliverables of clinical studies under Encoded Dravet program
- Perform independent validation and in-depth review of SDTM and ADaM datasets to ensure compliance with CDISC standards and study specifications, and regulatory requirements
- Review and validate tables, listings and figures (TLFs) supporting Clinical Study Reports (CSR), ISS and ISE
- Document validation findings and provide clear, actionable and timely review comments on CRO deliverables
- Support internal ad hoc analyses to address study questions, regulatory requests, or internal decision making
- Develop programming macros, templates and specifications to enable consistent, efficient programming practices across studies
- Collaborate closely with Biostatistics, Data Management, Clinical Development, Regulatory Affairs, and Quality Assurance to align on analysis plans, submission strategy, and timelines
- Actively manage study timelines, risks, and analysis changes, proactively identifying issues related to programming activities and data quality
Requirements
- Bachelor’s or Master’s degree in Biostatistics, Mathematics, Computer Science, or a related quantitative discipline, with 10+ (or 7+ years with a Master’s degree) of statistical programming experience in pharmaceutical, biotech or CRO environments
- Advanced SAS programming expertise in a clinical trial and regulatory setting; working knowledge of R, Python or other programming languages is a plus
- Demonstrated experience leading oversight, validation and in-depth review of CRO statistical programming deliverables
- Strong working knowledge of CDISC standards in SDTM, ADaM dataset structures, complex derivations, and traceability
- Experience contributing to or developing departmental programming tools such as macro libraries, specification templates, or automation tools
- Solid understanding of clinical drug development processes, data flow and cross-functional dependencies
- Excellent written and verbal communication skills, with the ability to provide clear, actionable technical feedback to CRO partners and internal stakeholders
- Highly self-motivated, detail-oriented, and able to manage multiple tasks, adapt to shifting priorities and perform effectively under tight timelines in a fast-paced environment
Benefits
- Comprehensive benefits package, including competitive employer premium contributions
- Meaningful stock option grants
- PTO, sick time, and holiday pay
- Generous Parental Leave program
- Pre-tax medical and dependent care programs
- STD, LTD, Life and AD&D
- Professional development opportunities
- Team-building events
- Fully stocked kitchen
- Fitness center at our SF headquarters
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