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 medicines.
Role type
Senior Manager, Statistical Programming
Builds
Clinical data analysis datasets, regulatory submission components (e-submission), and robust programming specifications (ADaM, SDTM)
Domain
Biopharmaceuticals / Clinical Data Management
Required skills
SAS programming, CDISC standards (SDTM, ADaM), clinical trial methodology, regulatory guidance, relational databases, upstream data processing, downstream deliverable creation, change management, risk remediation
Preferred skills
Vendor management, electronic submission preparation, process improvement initiatives
Technologies
SAS, MS Office, XML, Pinnacle 21, eDC, SDTM, ADaM
Responsibilities
Provide comprehensive programming leadership to clinical project teams and vendors; Independently develop, validate, troubleshoot, and maintain complex programs; Lead electronic submission preparation and review; Develop unambiguous programming specifications; Review key planning documents to align with project objectives; Identify and remediate issues/risks to facilitate decision making
Seniority
Senior, hands-on IC with team leadership
