Jobs at Orion Corporation

Lead development, validation, and delivery of clinical trial analysis datasets and submission-ready outputs (ADaM, TLFs, define.xml) following CDISC and regulatory standards. Support data cleaning, submission packages (Pinnacle 21), automation/AI-assisted workflows, and mentor junior programmers across Phase I-III oncology studies.

Lead clinical data management for oncology Phase I-III trials from startup through database lock. Design and review eCRFs and database builds, manage external data integration (imaging, genomics, biomarkers, ePRO), ensure CDISC/SDTM readiness, oversee queries, coding, regulatory submission support, and drive data quality and automation initiatives.

Provide statistical design, analysis, interpretation, and reporting support for Phase I-III oncology trials with emphasis on biomarker, translational, and precision medicine analyses. Develop SAPs, mock TLFs, execute and validate analyses, ensure CDISC compliance, collaborate with clinical, programming, and translational teams, and contribute to regulatory submissions and scientific communications. Support evaluation of AI-assisted tools and automation to improve statistical workflows.

Lead development and activation of Orion Pharma's corporate brand and reputation globally. Shape positioning, messaging, and guidelines; drive campaigns and content; use data and insights to optimize performance; coordinate cross-functional stakeholders and markets; support measurement, reputation integration, and continuous improvement.

Lead statistician for oncology development programs, providing statistical strategy and oversight across Phase I-III trials. Develop study designs, SAPs, protocols, and contribute to regulatory submissions (NDA/BLA/MAA). Advance statistical methodologies (Bayesian, adaptive), evaluate AI-enabled analytics, and partner with Data Sciences and Statistical Programming to implement AI-assisted workflows and ensure high-quality biostatistics deliverables for registrational programs.

Lead statistical programming for oncology clinical programs from startup through regulatory submission. Deliver and QC SDTM/ADaM/define.xml/TLFs, ensure regulatory compliance, implement standards and automation, collaborate with cross-functional teams, mentor programmers, and support global submissions (NDA/BLA/MAA).

Lead end-to-end clinical data management for oncology Phase I-III studies, overseeing eCRF/database design, external data integration, data review, query resolution, and database lock. Ensure CDISC/ICH-GCP compliance, support inspections/submissions, manage CROs and vendors, drive process improvements and implement AI-assisted review and automation to deliver inspection- and submission-ready datasets.