Lead Biostatistician, Biostatistics, R&D, Orion Corporation
About The Position
You will join a growing oncology-focused Data Sciences function and provide strategic statistical leadership for oncology drug development programs across Phase I–III clinical development. This role is responsible for developing and executing statistical strategies that support study design, regulatory submissions, data interpretation, and key development decisions across the oncology portfolio. The Lead Biostatistician serves as a key representative of Biostatistics on cross-functional teams and contributes to the growth, development, and continuous improvement of the broader Data Sciences organization.
Requirements
- PhD or MSc in Statistics, Biostatistics, or a related field (PhD preferred)
- 10+ years of experience in clinical drug development, oncology preferred
- Extensive regulatory experience (FDA, EMA, ICH), including leading or contributing to multiple marketing submissions
- Deep expertise in oncology; experience in IO and/or ADC is a strong advantage
- Strong command of advanced statistical approaches (e.g. Bayesian and adaptive designs) and their application in oncology
- Excellent leadership, strategic-thinking, collaboration, and communication skills
- Understanding of AI-assisted statistical workflows and emerging technologies applicable to drug development and evidence generation.
Responsibilities
- Provide scientific and strategic biostatistics leadership for oncology portfolio across Phase I-III studies
- Contribute to clinical development plans, study designs, and evidence-generation strategies as a core member of program teams
- Serve as the lead statistician for assigned development programs and represent Biostatistics on cross-functional study and program teams.
- Lead the development and review of protocols, statistical analysis plans (SAPs), clinical study reports, and other key study documents.
- Ensure delivery of biostatistics outputs across the portfolio in line with timelines, budget, quality, and compliance expectations
- Provide statistical leadership for regulatory submissions (e.g. NDA/BLA/MAA) and health authority interactions
- Define, standardise, and drive implementation of statistical methodologies, standards, and best practices across the function
- Represent biostatistics in governance forums, cross-functional leadership teams, and external collaborations
- Advance the application of advanced and innovative statistical approaches (e.g. Bayesian and adaptive statistical methods)
- Lead the evaluation and adoption of AI-enabled analytics, automation, and advanced decision-support capabilities across the Biostatistics function
- Partner with Data Sciences and Programming leaders to identify opportunities for AI-assisted evidence generation and operational efficiency improvements.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
