Manager / Senior Manager, Statistical Programming (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

Statistical Programming Languages, Statistical Programming Languages, Biotech and Pharmaceutical, Contract Research Organization (CRO), Biometrics, Computer Programming, Data Sets, Data Management, Biostatistics, Clinical Data, 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