Manager, Statistical Programming
Core
Lead statistical programming and analysis to produce high-quality datasets, tables, figures, and listings for regulatory study reports and integrated summaries.
Role type
Manager, Statistical Programming (Analysis)
Builds
Regulatory submission packages (NDA, BLA, MAA) and integrated analysis summaries for FDA and global agencies.
Domain
Pharmaceutical/Biotech clinical trials and regulatory submissions
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAS programming and macro development, CDISC standards (CDASH, SDTM, ADaM), clinical trial design and reporting, regulatory submission processes (FDA, PMDA, EMA), statistical analysis, project management, stakeholder negotiation
Preferred skills
Oncology/hematology/virology/inflammation therapeutic area experience, pivotal study experience, complex fast-turnaround programming, advanced statistical programming processes knowledge
Technologies
SAS, CDISC standards (CDASH, SDTM, ADaM)
Responsibilities
Collaborate with Clinical Development to meet project timelines, generate programming deliverables for study reports, ensure compliance with departmental procedures and regulatory standards, resolve study-related issues, negotiate timelines and secure buy-in
Seniority
Manager, hands-on IC with team leadership
