Hybrid Senior Manager, Statistical Programming

at Encoded Therapeutics Inc.

• Job title: Senior Manager, Statistical Programming
• Job type: Full Time
• Experience level: Senior
• Salary: $150,000 - $210,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Python
• Location requirements: Hybrid, South San Francisco, United States

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