Description

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. 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.

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.

Senior Manager, Statistical Programming

Description

Requirements

Encoded Therapeutics

Pipeline