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