Senior Manager, Statistical Programming - Oncology Early Development
Core
Oversees statistical programming and analysis for oncology early development clinical projects, ensuring data integrity and high-quality analysis for first-in-human trials up to proof of concept.
Role type
Senior Manager, Statistical Programming
Builds
Analysis datasets (ADaM), Tables, Listings, Figures (TLFs), and regulatory documentation for oncology clinical trials.
Domain
Oncology, Clinical Drug Development, Regulatory Filings
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
SAS programming, CDISC standards, ADaM data set creation, team leadership, resource planning, regulatory filing experience, standard SAS macro development, SOP creation, staff mentoring, recruitment.
Preferred skills
None stated.
Technologies
SAS, CDISC standards.
Responsibilities
Leads statistical programming activities for compounds or therapeutic areas; manages team of statistical programmers and resource planning; ensures timely deliverables and quality processes; develops and oversees SAS programs for ADaM data sets and TLFs; creates documentation for regulatory filings; leads development of standard SAS macros and SOPs; mentors staff and creates career development plans; participates in staff recruitment.
Seniority
Senior Manager, hands-on IC with team leadership