A commercial-stage biotech is looking to bring on a Principal/Associate Director, Statistical Programming to provide programming leadership across its clinical portfolio, in all phases of development. This is a hands-on, high-visibility role in a lean biometrics team, combining study-level delivery with CRO oversight and submission work.
Responsibilities
Lead programming delivery for assigned studies, from database build through to readout and archival
Develop and validate SDTM and ADaM datasets, specifications and submission-ready CDISC deliverables, including define.xml, reviewer's guides and Pinnacle 21 reports
Produce and QC TLFs for blinded dry runs, final reporting and ad hoc analyses
Support integrated summaries (ISS/ISE), DSURs and rapid turnaround on regulatory requests
Oversee CRO and vendor programming, holding partners to timelines and quality standards
Partner with biostatistics, data management and clinical colleagues, including input into analysis plans and CRF/EDC review
Support medical affairs, scientific communications and payer-facing analyses as needed
Mentor programmers and contribute to programming standards, macro libraries and processes
Experience Required
Masters in Computer Science, Biostatistics, Mathematics or a related field with 6+ years of experience, or Bachelor's with 8+ years
Expert SAS programming skills; R experience a plus
Advanced, hands-on SDTM and ADaM implementation to CDISC standards
Experience leading a Phase 2 or Phase 3 study reporting effort end to end
Regulatory submission experience, including define.xml, reviewer's guides and eCTD
Demonstrable experience overseeing CRO programming deliverables and mentoring programmers
Hands-on and detail-driven, comfortable in a fast-moving, cross-functional environment
Compensation $140-$240k - competitive base salary + bonus, equity and supporting package