Associate Director, Statistical Programming
Core
Lead statistical programming activities for clinical trials, ensuring quality and timely delivery of deliverables for studies or regulatory submissions.
Role type
Senior IC statistical programming manager (clinical trials)
Builds
Validated SAS and R programs, CDISC-compliant datasets (SDTM, ADaM), and regulatory submission packages
Domain
Pharmaceutical clinical development and regulatory submissions
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
SAS programming (Base, Macro, STAT, SQL, Graph), CDISC standards (SDTM, ADaM, Define XML), statistical analysis plan implementation, vendor management, technical specification writing, global macro development, SOP creation
Preferred skills
R programming (data visualization, exploratory analysis), Posit Workbench/RStudio Server, enterprise R environments
Technologies
SAS, R, Posit Workbench, RStudio Server
Responsibilities
Provide technical leadership for statistical programming across clinical studies and NDA/BLA submissions; Collaborate with Biostatistics to develop and validate CDISC ADaM specifications and TLFs; Partner with Data Management on SDTM specifications and with Drug Safety/Clinical Pharmacology on data review; Manage internal teams and vendor/CRO programming support; Write and validate complex SAS/R code for tables, listings, figures, and analysis datasets; Plan and coordinate project work to ensure timely delivery; Develop programming processes and standardization efforts consistent with industry best practices; Review and provide expert input on DMP, eCRF specs, and statistical analysis plans.
Seniority
Senior, hands-on IC with management responsibilities
