Senior Manager - Statistical Programming
Core
Lead statistical programming teams to design, develop, and implement technical solutions for integrating, analyzing, and reporting clinical data to support regulatory approval and market acceptance of pharmaceutical products.
Role type
Senior Manager, Statistical Programming
Builds
Clinical data analysis datasets, regulatory submissions (e-submission components), and robust programming specifications (e.g., ADaM, SDTM)
Domain
Pharmaceutical / Clinical Data Management / Regulatory Affairs
Required skills
SAS programming, CDISC standards (SDTM, ADaM), relational databases, clinical trial methodology, regulatory guidance, statistical concepts, upstream data processing, downstream deliverable creation, change management, risk remediation
Preferred skills
None stated
Technologies
SAS, MS Office, XML, Pinnacle 21, eDC, SDTM, ADaM
Responsibilities
Provide comprehensive programming leadership and support to clinical project teams and vendors; Independently develop, validate, troubleshoot, and maintain complex programs and utilities; Lead electronic submission preparation and review; Develop unambiguous and robust programming specifications; Review key planning documents to align with project objectives; Identify and lead opportunities to enhance processes and technology
Seniority
Senior Manager, hands-on IC with team leadership
