Teams at Oruka Therapeutics

Provides statistical leadership for Phase I–IV clinical development programs. Leads study design, protocol development, statistical analysis plans, clinical study reports, regulatory submissions, and interpretation of trial results. Oversees biostatistical timelines, CROs, data management and programming deliverables, and statistical programming. Partners with Clinical and Regulatory teams while ensuring compliance with FDA, EMA, ICH-GCP, CDISC, and company standards.

Leads biostatistical execution for Phase I–IV clinical trials, including study design, statistical analysis plans, protocol development, reporting, and interpretation of results. Authors and reviews clinical documents, develops statistical programs, oversees CRO biostatistics vendors, and ensures compliance with SOPs, ICH-GCP, FDA/EMA regulations, and CDISC standards. Collaborates cross-functionally while managing timelines, deliverables, risks, and ad hoc analyses in a fast-paced biotech environment.

Leads technical development and program execution for pharmaceutical combination device platforms, including autoinjectors and prefilled syringes. Responsibilities include design controls, risk management, verification and validation, human factors support, supplier and CDMO oversight, technology transfer, manufacturing campaigns, investigations, CAPAs, regulatory submission support, and cross-functional project management. The role requires hands-on device engineering expertise, external partner management, and approximately 20–30% international and domestic travel.