Manager - Statistical Programming (Hybrid)
Core
Strategic leadership of statistical programming activities for neuroscience product development, guiding teams in creating regulatory-grade data sets and documentation.
Role type
Manager, Statistical Programming (Neuroscience)
Builds
ADaM data sets, Tables, Listings, Figures (TLFs), and regulatory documentation for early development compounds.
Domain
Pharmaceutical / Neuroscience / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
SAS programming, CDISC standards, ADaM development, TLF generation, team leadership, resource planning, quality process management, regulatory filing oversight, standard SAS macro development, mentoring
Preferred skills
Regulatory filing experience
Technologies
SAS
Responsibilities
Lead statistical programming activities for a compound/indication or therapeutic area in early development; Lead a team of statistical programmers and manage resource planning; Ensure timely deliverables and adherence to quality processes; Develop and oversee SAS programs for ADaM data sets and TLFs; Create documentation for regulatory filings; Develop standard SAS Macros and SOPs; Provide oversight and mentoring to statistical staff.
Seniority
Manager, hands-on IC with team leadership