Manager, Statistical Programming
Core
Lead statistical programming activities supporting clinical development and regulatory submissions by developing, validating, and maintaining SAS and R programs.
Role type
Manager, Statistical Programming
Builds
CDISC-compliant SDTM and ADaM datasets, efficacy and safety Tables, Listings, and Figures (TFLs) for clinical study reports and regulatory submissions
Domain
Clinical research / Biopharmaceuticals
Required skills
SAS programming, R programming, CDISC standards (SDTMIG, ADaMIG), clinical trial design, statistical reporting, regulatory requirements, code review, process improvement
Preferred skills
Experience with Define.xml, SDRG, ADRG, P21 reports, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), international team collaboration
Technologies
SAS, R
Responsibilities
Independently develop, validate, maintain, and quality-check SAS and R programs; Develop and validate SDTM and ADaM datasets; Program, generate, review, and validate efficacy and safety TFLs; Collaborate with cross-functional teams to resolve data issues; Participate in code reviews and debugging; Contribute to programming documentation and reusable assets; Identify opportunities for process improvement; Provide technical guidance to junior programmers
Seniority
Manager, hands-on IC with team oversight