Principal / Associate Director, Statistical Programming (Remote)
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