[Hiring] Manager / Senior Manager, Statistical Programming @Astera Search

Role Description

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. 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.

• 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

Qualifications

• 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

Requirements

• Compensation DOE - $160-200k + bonus, lucrative equity and supporting package