Assoc Director, Statistical Programming
Core
Lead statistical programming and analysis for clinical study reports and regulatory submissions in oncology, hematology, virology, and inflammation.
Role type
Senior IC statistical programmer (Associate Director)
Builds
Regulatory submission packages (integrated summaries, tables, listings) for FDA/PMDA filings
Domain
Pharmaceutical clinical trials (Oncology, Hematology, Virology, Inflammation)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAS programming, SAS Macros, CDISC standards (CDASH, SDTM, ADaM), clinical trial design, regulatory reporting (FDA/PMDA), GCP/ICH compliance, project management, stakeholder negotiation
Preferred skills
Oncology/Hematology/Virology therapeutic area experience, pivotal study experience, integrated analysis, complex fast-turnaround programming
Technologies
SAS, CDISC
Responsibilities
Direct design and coding of analysis files, generate programming deliverables for study reports, anticipate resource needs, lead strategic initiatives for the programming group, resolve study-related issues and conflicts, manage critical deadlines
Seniority
Senior, hands-on IC with leadership responsibilities