| Location | (Remote) |
A clinical-stage biotech is looking to bring on a Manager/Senior Manager, Statistical Programming to drive programming delivery on its pivotal Phase 3 program. Coming off a standout Phase 2 readout with potentially practice-changing data, the company is scaling its pipeline, with further indications to follow.
This is a hands-on, execution-focused role in a growing biometrics function, and a real opportunity for an experienced CRO programmer to make the move to sponsor side.
Responsibilities
Own statistical programming delivery for a pivotal Phase 3 program, through to submission
Hold CRO partners accountable for programming deliverables, quality and timelines
Develop, validate and review SDTM and ADaM datasets and TLFs, hands-on
Review CRO specifications, define packages and submission-ready outputs
Partner closely with biostatistics, data management and clinical colleagues to keep deliverables on track
Influence programming strategy, standards and processes as the function grows
Support new studies from set-up as further indications are added
Adapt quickly as priorities shift with the program
Experience Required
Bachelor's or Masters in Statistics, Computer Science, Life Sciences or a related field
Solid clinical statistical programming experience within pharma, biotech or a CRO
Advanced SAS programming skills; R experience a plus
Strong working knowledge of CDISC standards (SDTM, ADaM) and submission deliverables
Late-stage experience; CRO candidates looking to transition to a sponsor are very welcome
Experience coordinating or overseeing outsourced programming work
Self-directed and reliable, comfortable in a lean, fast-moving environment
Compensation DOE - $160-200k + bonus, lucrative equity and supporting package