Jobs at Orion Pharma

Lead clinical data management for oncology Phase I-III trials from startup through database lock. Oversee eCRF/database design, edit checks, vendor data integration (imaging, genomics, ePRO, labs), coding (MedDRA, WHODrug), query resolution, CDISC compliance, and submission readiness. Partner with cross-functional teams, support inspections, and drive automation and AI-enabled data quality improvements.

Lead strategic and operational clinical data management across oncology Phase I-III programs. Drive data strategy, eCRF/database design, external data integration, CDISC compliance, database lock activities, CRO/vendor oversight, inspection/submission readiness, data quality initiatives, AI/automation adoption, and cross-functional alignment to support regulatory submissions and development decisions.

Lead statistical programming for oncology clinical development (Phase I-III). Ensure timely, regulatory-compliant delivery of SDTM/ADaM, TLFs, define.xml and submission materials; define standards, drive automation and AI adoption, collaborate with cross-functional teams, and mentor programmers.

Provide statistical leadership for Phase I-III oncology trials, focusing on biomarker, translational, and precision medicine analyses. Design protocols, define endpoints and sample sizes, produce SAP-based analyses and TLFs, ensure CDISC-compliant deliverables, support regulatory reporting, and collaborate with clinical, translational, programming, and external partners. Evaluate AI-assisted tools and advanced analytics to improve workflows.

Provide strategic biostatistics leadership for oncology Phase I-III programs: design studies, develop SAPs, support regulatory submissions, lead cross-functional teams, standardize methodologies, advance Bayesian and adaptive methods, and drive adoption of AI-enabled analytics and automation across the Biostatistics function.

Lead development, validation, and delivery of SDTM/ADaM datasets, TLFs, and regulatory submission packages for oncology clinical studies. Ensure CDISC compliance, perform QC, collaborate with biostatistics and data management, support submissions to FDA/EMA, drive automation/AI workflows, and mentor junior programmers.

Lead corporate brand strategy and activation for Orion Pharma, translating company strategy into messaging, toolkits and content. Drive campaigns, collaborate across global teams, use data and insights to optimize brand performance, and support reputation measurement, stakeholder alignment, and integrated campaign execution.