Associate Director, Statistical Programming
Core
Lead statistical programming activities across multiple clinical trials, ensuring high-quality deliverables, operational consistency, and adherence to timelines for genetically driven neuromuscular disease therapeutics.
Role type
Senior IC statistical programming lead (clinical trials)
Builds
Production clinical datasets (CDISC SDTM/ADaM), tables, listings, and figures (TLFs) for regulatory submissions
Domain
Biotechnology / Clinical Development / Neuromuscular Diseases
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
SAS (advanced proficiency), CDISC standards (SDTM, ADaM), regulatory submission requirements (eCTD, FDA, EMA), statistical programming, data standards, vendor management, automation tool development
Preferred skills
R, Python, multi-study experience, leadership of small programming teams
Technologies
SAS, R, Python, eCTD
Responsibilities
Lead and oversee statistical programming activities across multiple clinical trials; Develop, validate, review, and maintain analysis datasets (CDISC standards), tables, listings, and figures (TLFs); Review statistical analysis plans (SAPs) and provide strategic input; Perform complex statistical analyses and simulations; Coordinate and oversee vendor/FSP statistical programming activities; Build, maintain, and promote reusable, software-agnostic tools, macros, and automation solutions; Mentor and provide technical guidance to junior programmers
Seniority
Senior, hands-on IC with leadership responsibilities
