Associate Director, Biostatistics, R&D, Orion Corporation

Orion Pharma•Boston, MA

3d•$130,000 - $300,000•Hybrid

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 Associate Director of Biostatistics 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.