Senior Manager, Statistical Programming
About The Position
Encoded Therapeutics is a biotechnology company combining the precision of gene regulation with the versatility of gene therapies to create breakthrough treatments for individuals living with severe genetic diseases. For more information, please visit www.Encoded.com. Reporting to the Director of Statistical Programming, the Senior Manager of Statistical Programming serves as internal technical programming owner and oversight lead for statistical programming activities supporting clinical studies within Encoded Dravet program. This role is responsible for independent validation, in-depth review, and quality oversight of CRO-produced statistical programming deliverables, including SDTM, ADaM, TFLs, and submission-related documentation. This is a hands-on, individual contributor role requiring strong technical expertise in CDISC standards, regulatory programming, and CRO oversight, combined with the ability to manage timelines, risks, and frequent study changes in a fast-paced, sponsor-led biotech environment. While the role does not initially include direct people management, it carries senior-level accountability for ensuring programming quality, consistency, and submission readiness across studies.
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
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
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
- Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
